EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries (ORION)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Iliac Artery Stenosis |
Device: Epic™ Nitinol Stent System Drug: Anti-platelet therapy Drug: Anti-coagulation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries |
- Device- and/or Procedure-related Major Adverse Events (MAE) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
- Death [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
- Death [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
- Death [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
- Death [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
- Death [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
- Amputation of Index Limb [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
- Amputation of Index Limb [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
- Amputation of Index Limb [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
- Amputation of Index Limb [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
- Target Vessel Revascularization (TVR) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Vessel Revascularization (TVR) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Vessel Revascularization (TVR) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Vessel Revascularization (TVR) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.
A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Myocardial Infarction (MI) [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.
- Technical Success [ Time Frame: Index procedure ] [ Designated as safety issue: No ]Residual lesion stenosis <=30% based on visual assessment immediately postprocedure
- Procedure Success [ Time Frame: In hospital (1-2 days post procedure) ] [ Designated as safety issue: Yes ]Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).
- Early Clinical Success [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Early Clinical Success [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Late Clinical Success [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Late Clinical Success [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Early Hemodynamic Success [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
- Early Hemodynamic Success [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
- Late Hemodynamic Success [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
- Late Hemodynamic Success [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
- Rutherford Classification Distribution [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]
Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
- = Mild claudication
- = Moderate claudication
- = Severe claudication
- = Ischemic rest pain
- = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Rutherford Classification Distribution [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
- = Mild claudication
- = Moderate claudication
- = Severe claudication
- = Ischemic rest pain
- = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Rutherford Classification Distribution [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Rutherford Classification is used to assess lower extremity ischemia as shown below:
0 = Asymptomatic
- = Mild claudication
- = Moderate claudication
- = Severe claudication
- = Ischemic rest pain
- = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
- Rutherford Classification Distribution [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss
- Rutherford Classification Distribution [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Rutherford Classification is used to assess lower extremity ischemia as shown below:
Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss
- Acute Stent Thrombosis [ Time Frame: 24 Hours ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure.
- Sub-acute Stent Thrombosis [ Time Frame: >24 Hours to <=30 Days Post-index procedure ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure.
- Stent Thrombosis [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.
- Stent Thrombosis [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.
- Stent Thrombosis [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Very late stent thrombosis is defined as >365 days following the trial procedure.
- Stent Thrombosis [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion
Very late stent thrombosis is defined as >365 days following the trial procedure.
- Target Lesion Revascularization (TLR) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Lesion Revascularization (TLR) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Lesion Revascularization (TLR) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Lesion Revascularization (TLR) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Target Lesion Revascularization (TLR) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
- Ankle-Brachial Index (ABI) [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
- Ankle-Brachial Index [ Time Frame: Hospital Discharge (1-2 days post-procedure) ] [ Designated as safety issue: No ]
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
- Ankle-Brachial Index (ABI) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
- Ankle-Brachial Index (ABI) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
- Ankle-Brachial Index (ABI) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
- Primary Patency [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
- Primary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
- Primary-assisted Patency (PAP) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
- Primary-assisted Patency (PAP) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
- Secondary Patency [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
- Secondary Patency [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
- Restenosis Assessed by Duplex Ultrasound [ Time Frame: 9 Months ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
- Restenosis Assessed by Duplex Ultrasound [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
- Walking Impairment Questionnaire Score - Distance [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Distance [ Time Frame: 9 Months ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Distance [ Time Frame: 1 Year ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Speed [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Speed [ Time Frame: 9 Months ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Speed [ Time Frame: 1 Year ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score-Stair Climbing [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Stair Climbing [ Time Frame: 9 Months ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
- Walking Impairment Questionnaire Score - Stair Climbing [ Time Frame: 1 Year ] [ Designated as safety issue: No ]The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
| Enrollment: | 125 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ORION
All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
|
Device: Epic™ Nitinol Stent System
The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.
Drug: Anti-platelet therapy
Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.
Drug: Anti-coagulation therapy
Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)
- Lifestyle-limiting claudication or rest pain
- De novo or restenotic lesions in the common and/or external iliac artery
- Subjects with bilateral disease may have only one target lesion treated per side
- Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
- Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents
- Baseline diameter stenosis >= 50% (operator visual assessment)
- Reference vessel diameter >= 5 mm and <=11 mm
- At least one sufficient ipsilateral infrapopliteal run-off vessel
- Origin of profunda femoris artery is patent
Exclusion Criteria:
- Target vessel with in-stent restenosis
- Acute critical limb ischemia
- Tissue loss (Rutherford/Becker category 5 or 6)
- Any major amputations to the target limb
- Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.
- Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
- Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- Platelet count < 150,000 mm3 or > 600,000 mm3
- Serum creatinine > 2.0 mg/dL
- Dialysis-dependent end stage renal disease
- Pregnancy
- Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
- Known allergy to Nitinol
- Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
- Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
- Target lesion is within or near an aneurysm
- Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
- Perforated vessel as evidenced by extravasation of contrast media
- Vascular graft, aneurysm or postsurgical stenosis of the target vessel
- Multiple lesions in the same target vessel unable to be treated with a maximum of two stents
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00896337
Show 28 Study Locations
| Study Director: | Pamela G. Grady, Ph.D. | Boston Scientific Corporation |
| Principal Investigator: | Daniel G Clair, MD | The Cleveland Clinic |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00896337 History of Changes |
| Other Study ID Numbers: | S2020 |
| Study First Received: | May 8, 2009 |
| Results First Received: | April 10, 2012 |
| Last Updated: | April 17, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Scientific Corporation:
|
iliac artery stenosis claudication atherosclerotic iliac disease peripheral vascular disease |
Additional relevant MeSH terms:
|
Constriction, Pathologic Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on September 26, 2016