Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

Study Overview
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Brief Summary
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Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery? Alternative hypothesis: Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months Null hypothesis: Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints? How do the intervention methods compare in terms of safety/incidence of adverse effects? What are the long-term clinical implications of the two treatment methods?

Official Title
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Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting

Conditions
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Popliteal Artery

Intervention / Treatment
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* Device: Lifestent
* Device: balloon-angioplasty (PTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is at least 21 years old The patient or legal representative provided written informed consent The patient agrees to comply with the protocol-mandated follow-up visits and testing regime The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category The target lesion located within the popliteal artery has angiographic evidence of stenosis > 70% or occlusion (by visual estimate) At least one vessel runoff to the foot The patient has no other relevant inflow or outflow stenosis (> 50%), however when needed iliac or femoral intervention may be done during study procedure. Exclusion Criteria: The patient is currently participating in a drug or another device study. The popliteal artery target lesion has previously been subintimal recanalized The patient has a history of bleeding diatheses or coagulopathy Female patients that are pregnant The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin The patient is unable to conform to the study protocol follow-up procedures or visits. The patient has a life expectancy of <24 months The patient has concomitant renal failure which requires dialysis The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria: The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract The popliteal artery target lesion is restenotic The popliteal artery has been subintimal recanalized

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Percutaneous transluminal angioplasty (PTA) | Device: balloon-angioplasty (PTA)<br>* PTA for endovascular treatment of popliteal artery lesions<br>|
| Active Comparator: 2<br>Primary stenting | Device: Lifestent<br>* Stent for endovascular treatment of popliteal artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s) |  | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency |  | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerotic, lesions