ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Study Overview
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Brief Summary
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The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.

Detailed Description
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The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm). Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.

Official Title
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Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters: 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and 20 mm from the proximal margin of the intercondylar fossa. Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel Target vessel reference diameter visually estimated to be > 4.0 mm and < 7.0 mm Target lesion length visually estimated to be > 40 mm and < 200 mm If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator At least one-vessel run-off to the foot confirmed by baseline angiography Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of < 30% without death, stroke, bleeding requiring > 2 units transfusion, or any other complication which was device or procedure related. Patient is acceptable candidate for femoral-popliteal artery bypass surgery Exclusion Criteria: Previous ipsilateral femoro-popliteal or femoro-tibial surgery Presence of a stent in the target vessel Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries Acute thrombophlebitis or deep vein thrombus Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy Hemodynamic instability Target lesion is restenotic from previous intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>The purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. | Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent<br>* A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound). |  | At 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically driven target lesion revascularization |  | at 12 and 24 month follow-up | 
| Target lesion primary, primary assisted and secondary patency rates |  | at 6, 12 and 24 month follow-up | 
| Major complications |  | at 1, 6, 12 and 24 month follow-up | 
| Angiographic binary restenosis rate in a subset of patients |  | at 9 month follow-up | 
| Device and procedure success |  | Acute | 
| Vascular and bleeding complications (local and puncture site) |  | 1, 6, 12, 24 months | 
| Stent fracture determined by biplane X-ray |  | at 12 month follow-up | 
| Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound) |  | 365 days and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Disease, Restenosis Rate, Patency Rates, Self-Expandable Nitinol Stents, Stent Fractures