Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia

Study Overview
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Brief Summary
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This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.

Detailed Description
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This is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.

Conditions
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Atherosclerosis, Ischemia

Intervention / Treatment
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* Device: plaque excision system
* Device: Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial disease Disease located within the femoropopliteal artery Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion. Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater. Exclusion Criteria: Previously implanted stent(s) or stent graft(s) in target leg Life expectancy less than 12 months Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days. Receiving dialysis or immunosuppressant therapy. Recent stroke within past 90 days. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed. Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6) Serum creatinine level >/= 2.5 mg/dl at time of screening visit Known or suspected active infection at the time of the procedure Bleeding diathesis Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol. Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser. Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Stents<br>Stents group | Device: Stent<br> <br> |
| Active Comparator: Intervention: Atherectomy<br>Direct Atherectomy group | Device: plaque excision system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month Primary Patency Rate | Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound. | 12 months | 
| 12-month Limb Salvage Rate | Limb Salvage is defined as the freedom from secondary major amputation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index Limb Ischemia at 6-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 6 months | 
| Index Limb Ischemia at 12-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 12 months | 
| Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization , and significant embolic events, which were defined as causing end-organ damage. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stents, atherectomy, femoral artery, popliteal artery