- Powered Secondary Endpoint: Composite of Limb Salvage and Primary Patency [ Time Frame: At 1 year ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Number of Participants with Acute Procedure Success [ Time Frame: Immediately after the procedure ]
Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus Esprit BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.
- Number of Participants with Device Success- for Esprit arm only [ Time Frame: During the procedure ]
Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
- Number of Participants with Technical Success [ Time Frame: Immediately after the procedure ]
Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.
- Number of Participants with Clinical Success [ Time Frame: Within 2 days after the index procedure or at hospital discharge ]
Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.
- Number of Participants with Angiographic acute gain (in-segment) [ Time Frame: Immediately after the procedure ]
Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).
- Number of Participants with Angiographic acute gain (in-device) [ Time Frame: Immediately after the procedure ]
Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for Esprit arm only
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 1 month ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 3 months ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 6 months ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 1 year ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 2 years ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 3 years ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 4 years ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Composite of Limb Salvage and Primary Patency [ Time Frame: At 5 years ]
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR). Primary patency ends at the first occurrence of one of the following: 100% total occlusion of the target vessel, clinically-driven target lesion revascularization, or above ankle amputation due to target lesion restenosis or occlusion.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 1 month (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 1 month and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 3 months (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion occurring within 3 months and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 6 months (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion occurring within 6 months and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 1 year (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 1 year and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 2 years (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 2 years and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 3 years (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 3 years and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 4 years (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 4 years and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) [ Time Frame: At 30 days (for POD) and 5 years (for MALE) ]
MALE includes major amputation or major re-interventions including new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis related to the target lesion at 5 years and POD includes peri-procedural (or peri-operative) death at 30-days.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 month ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 3 months ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 6 months ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 year ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 2 years ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 3 years ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 4 years ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Major Amputation and Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 5 years ]
Major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Freedom From Above Ankle Amputation [ Time Frame: At 1 month ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 3 months ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 6 months ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 1 year ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 2 years ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 3 years ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 4 years ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Above Ankle Amputation [ Time Frame: At 5 years ]
Freedom From Above Ankle Amputation will be assessed. Amputation will apply only to amputations of the limb that was treated.
- Freedom From Restenosis [ Time Frame: At 1 month ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 3 months ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 6 months ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 1 year ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 2 years ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 3 years ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 4 years ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Freedom From Restenosis [ Time Frame: At 5 years ]
Freedom from re-narrowing of the artery following the alleviation of a previous narrowing, as defined as the presence of a hemodynamically significant restenosis (≥ 50%), which is determined by angiography.
- Rate of Binary restenosis [ Time Frame: At 1 month ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 3 months ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 6 months ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 1 year ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 2 years ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 3 years ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 4 years ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Rate of Binary restenosis [ Time Frame: At 5 years ]
Binary restenosis will be presented as the presence of a hemodynamically significant restenosis ≥ 50% by angiography, or PSVR ≥ 2.4 by duplex ultrasound. In the presence of abnormal reference PSV, the core lab uses the following additional secondary criteria (correlating factors) to identify target lesion stenoses >50% in severity:
- Focal increase in the absolute PSV at the area of visible plaque
- Spectral broadening of the waveform at the area of stenosis
- Post-stenotic turbulence (PST) and/or change in the waveform shape and/or drop in velocity distal to the stenosis
- Review of the B-mode images for plaque burden
- Number of Amputation-free Survival [ Time Frame: At 1 month ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 3 months ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 6 months ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 1 year ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 2 years ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 3 years ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 4 years ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of Amputation-free Survival [ Time Frame: At 5 years ]
Amputation-free survival includes freedom from above ankle amputation and death.
- Number of All-cause Death [ Time Frame: At 1 month ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 3 months ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 6 months ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 1 year ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 2 years ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 3 years ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 4 years ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of All-cause Death [ Time Frame: At 5 years ]
All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
- Number of Participants with Arterial Thrombosis [ Time Frame: At 1 month ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 3 months ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 6 months ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 1 year ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 2 years ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 3 years ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 4 years ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Arterial Thrombosis [ Time Frame: At 5 years ]
Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms.
- Acute thrombosis: 0 - 24 hours post study procedure
- Subacute thrombosis: > 24 hours - 30 days post study procedure
- Late thrombosis: 31 days - 1 year post-procedure
- Very late thrombosis: > 1 year post-procedure
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 1 month ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 3 months ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 6 months ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 1 year ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 2 years ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 3 years ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 4 years ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Number of Participants with Major Re-intervention on index limb [ Time Frame: At 5 years ]
Major Limb Re-intervention includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
- Primary Assisted Patency [ Time Frame: At 1 month ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 3 months ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 6 months ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 1 year ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 2 years ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 3 years ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 4 years ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Primary Assisted Patency [ Time Frame: At 5 years ]
Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
- Secondary Patency [ Time Frame: At 1 month ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 3 months ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 6 months ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 1 year ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 2 years ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 3 years ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 4 years ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Secondary Patency [ Time Frame: At 5 years ]
Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 month ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 3 months ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 6 months ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 1 year ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 2 years ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 3 years ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 4 years ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) [ Time Frame: At 5 years ]
CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography. Bailout with metallic stent, in either study arm, due to acute closure or to achieve < 30% stenosis during index procedure will be considered a CD-TLR.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 1 month ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 3 months ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 6 months ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 1 year ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 2 years ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 3 years ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 4 years ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization (CD-TVR) [ Time Frame: At 5 years ]
CD-TVR is the repeat intervention on the target vessel due to recurrent symptoms AND stenosis > 70% by angiography.
Recurrent symptoms include delayed or worsening wound healing, new or recurrent wound at the treatment site, or worsening Rutherford class.
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 1 month ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 3 months ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 6 months ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 1 year ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 2 years ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 3 years ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 4 years ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Distal to the Target Lesion [ Time Frame: At 5 years ]
Clinically-driven Target Vessel Revascularization Distal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue distal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 1 month ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 3 months ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 6 months ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 1 year ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 2 years ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 3 years ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 4 years ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Number of Participants with Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion [ Time Frame: At 5 years ]
Clinically-driven Target Vessel Revascularization Proximal to the Target Lesion measures the CD-TVR that occurred at least 5 mm of tissue proximal to the target lesion
- Index Wound Assessment for Healing [ Time Frame: At 14 days ]
Index wound assessment for healing will be assessed by the core laboratory at 14 days
- Index Wound Assessment for Healing [ Time Frame: At 30 days ]
Index wound assessment for healing will be assessed by the core laboratory at 30 days
- Index Wound Assessment for Healing [ Time Frame: At 42 days ]
Index wound assessment for healing will be assessed by the core laboratory at 42 days
- Index Wound Assessment for Healing [ Time Frame: At 90 days ]
Index wound assessment for healing will be assessed by the core laboratory at 90 days
- Index Wound Assessment for Healing [ Time Frame: At 180 days ]
Index wound assessment for healing will be assessed by the core laboratory at 180 days
- Index Wound Assessment for Healing [ Time Frame: At 1 year ]
Index wound assessment for healing will be assessed by the core laboratory at 1 year
- Index Wound Assessment for Infection [ Time Frame: At 14 days ]
Index wound assessment for infection will be assessed by the core laboratory at 14 days.
- Index Wound Assessment for Infection [ Time Frame: At 30 days ]
Index wound assessment for infection will be assessed by the core laboratory at 30 days.
- Index Wound Assessment for Infection [ Time Frame: At 42 days ]
Index wound assessment for infection will be assessed by the core laboratory at 42 days.
- Index Wound Assessment for Infection [ Time Frame: At 90 days ]
Index wound assessment for infection will be assessed by the core laboratory at 90 days.
- Index Wound Assessment for Infection [ Time Frame: At 180 days ]
Index wound assessment for infection will be assessed by the core laboratory at 180 days.
- Index Wound Assessment for Infection [ Time Frame: At 1 year ]
Index wound assessment for infection will be assessed by the core laboratory at 1 year.
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At baseline ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 1 month ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 3 months ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 6 months ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 1 year ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 2 years ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 3 years ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 4 years ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb [ Time Frame: At 5 years ]
The Rutherford Becker scale is a classification system for claudication and limb ischemia.
Categories and Clinical Description:
Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
- Occurrence of new wound [ Time Frame: At 1 month ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 3 months ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 6 months ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 1 year ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 2 years ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 3 years ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 4 years ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Occurrence of new wound [ Time Frame: At 5 years ]
New wound is defined as wound below the knee in the index limb that was not identified at the time of the index procedure or wound that has recurred in the same location following the healing of the index wound. The new wound will be assessed firstly by the wound assessment core laboratory for etiology. Subsequently, the new wound will be evaluated by the site per protocol until the wound is healed through the 5-year follow-up.
- Number of patients with acute limb ischemia [ Time Frame: At 1 month ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 3 months ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 6 months ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 1 year ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 2 years ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 3 years ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 4 years ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with acute limb ischemia [ Time Frame: At 5 years ]
Acute Limb Ischemia is a rapid decrease in lower limb blood flow due to acute occlusion of peripheral artery or bypass graft.
- Number of patients with peripheral embolization [ Time Frame: At 1 month ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 3 months ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 6 months ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 1 year ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 2 years ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 3 years ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 4 years ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
- Number of patients with peripheral embolization [ Time Frame: At 5 years ]
Peripheral embolization refers to the evidence of distal embolization subsequent to the index procedure and peri-procedural period. Signs and symptoms suggest of peripheral embolization may include 1) acute change in vascular exam (sudden onset rest pain, pallor, coolness, or other signs of acute ischemia), 2) petechiae, or 3) sub-ungal hemorrhage.
