Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

Study Overview
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Brief Summary
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Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.

Official Title
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Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
* Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critical limb ischemia RC 4-6 Lesions in superficial femoral artery and popliteal artery (p1 -p2) Target vessel 4-8mm At least I 1 vessel runoff to the foot Age >18 years Exclusion Criteria: Pregnancy Patient disapproval Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Eluting Stent (DES)<br>Drug Eluting Stent (DES). Zilver PTX. | Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions<br>* Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries<br>|
| Placebo Comparator: Bare Metal Stent (BMS)<br>Bare Metal Stent (BMS). Zilver Flex | Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions<br>* Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 6 months | 
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 12 months | 
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 24 months | 
| Open (functioning and not stenosed) vascular reconstruction (Primary Patency) | Functioning revascularization without adjunctive measures | 12months | 
| Open (functioning and not stenosed) vascular reconstruction (Primary Patency) | Functioning revascularization without adjunctive measures | 24 months | 
| Event Free Survival | Alive without vascular events | 24 months |