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Data Registry Following Patients Using Supera Stent in the Femoral Arteries (STRONG)

This study has been terminated.
(Slow enrollment,increased loss to follow-ups and general lack of interest.)
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01154751
First received: June 29, 2010
Last updated: August 22, 2017
Last verified: August 2017
June 29, 2010
August 22, 2017
November 2008
August 2012   (Final data collection date for primary outcome measure)
  • Six-minute Walking Distance [ Time Frame: At baseline ]
    The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
  • Six-minute Walking Distance [ Time Frame: 30 days ]
    The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
  • Six-minute Walking Distance [ Time Frame: 6 months ]
    The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
  • Six-minute Walking Distance [ Time Frame: 1 Year ]
    The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Target Lesion Revascularization [ Time Frame: 6 months and 1 year ]
Target Lesion Revascularizatio (TLR)rates measured at 6 months and 1 year
Complete list of historical versions of study NCT01154751 on ClinicalTrials.gov Archive Site
  • Number of Participants Experiencing Peri-procedural and Post-procedural Complications [ Time Frame: 30 days ]
    Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
  • Number of Peri-procedural and Post-procedural Complications [ Time Frame: 30 days ]
    Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
  • Rutherford-Becker Clinical Category [ Time Frame: 30 days ]

    Rutherford/Becker Categories:

    0 - Asymptomatic, no hemodynamically significant occlusive disease.

    1. - Mild claudication.
    2. - Moderate claudication.
    3. - Severe claudication.
    4. - Ischemic rest pain.
    5. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
    6. - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
  • Restenosis by Duplex Ultrasound [ Time Frame: 6 months ]
    In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
  • Restenosis by Duplex Ultrasound [ Time Frame: 1 Year ]
    In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
  • Target Lesion Revascularization [ Time Frame: 6 months ]
    Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
  • Target Lesion Revascularization [ Time Frame: 1 Year ]

    Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.

    Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)

  • Stent Fracture [ Time Frame: 1 Year ]
    Stent fractures determined by fluoroscopy .
  • Stent Fracture [ Time Frame: 1 to 2 years ]

    Stent fracture and Involuntary stent migration are types of device System Failure.

    Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

  • Stent Fracture [ Time Frame: 1 to 3 Years ]

    Stent fracture and Involuntary stent migration are types of device System Failure.

    Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.

  • Target Limb Ankle Brachial Index (at Rest) [ Time Frame: At baseline ]

    Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

    The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

  • Target Limb Ankle Brachial Index (at Rest) [ Time Frame: 30 days ]

    Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

    The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

  • Target Limb Ankle Brachial Index (at Rest) [ Time Frame: 6 months ]

    Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

    The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

  • Target Limb Ankle Brachial Index (at Rest) [ Time Frame: 1 Year ]

    Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

    The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

  • Target Limb Ankle Brachial Index (at Rest) [ Time Frame: 2 Years ]

    Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.

    ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure

    The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.

  • Six-minute Walking Distance [ Time Frame: 2 Years ]
    The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Not Provided
Not Provided
Not Provided
 
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Supera Treatment Registry Observing Neointimal Growth
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.

This registry follows up to 200 patients for at least 5 years.

The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Peripheral Artery Disease
  • Femoropopliteal Artery Stenosis
  • Peripheral Vascular Disease
Device: SUPERA Interwoven self-expanding nitinol stent
Insertion of stent at stenotic area
Device SUPERA Stent
SUPERA Interwoven Self-Expanding Nitinol Stent System
Intervention: Device: SUPERA Interwoven self-expanding nitinol stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
August 2015
August 2012   (Final data collection date for primary outcome measure)

Exclusion Criteria:

(Clinical)

  • Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
  • Rutherford-Becker classification 2 through 5 only
  • Patient is at least 18 years of age and of legal age of consent.
  • Patient must be willing to participate in the registry for at least 5 years.

(Angiographic)

  • Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
  • All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
  • All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
  • Target lesion length 1-20 cm (visual estimate)
  • Target lesion stenosis ≥50% (visual estimate)
  • Popliteal artery patent if the lesion is in the SFA
  • SFA patent if the lesion is in the popliteal artery
  • At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)

Exclusion Criteria:

(Clinical)

  • Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
  • Patient is participating in a clinical study that could confound results
  • Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.

(Angiographic)

  • Target lesion length > 20 cm
  • Instent restenotic / reoccluded target lesion
  • Acute (≤ 4 weeks) thrombotic occlusion
  • Untreated ipsilateral pelvic stenosis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01154751
IDEV Technologies, Inc.
No
Not Provided
Not Provided
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Thomas Zeller, Prof Dr med Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
Abbott Vascular
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP