Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases

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 Iliac artery occlusive disease.

Detailed Description
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This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease

Official Title
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Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases

Conditions
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Iliac Artery Occlusion

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients have non thrombotic arteriosclerosis obliterans of the common iliac or external iliac arteries Clinical diagnosis of stenosis or occlusive disease The patients have unobstructed distal outflow tract Receiving surgical treatment at the same time Exclusion Criteria: The patients who have 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. Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser. Patients are 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: 40 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: Stent<br>Stent group | Device: stent<br>* stent<br>|
| Active Comparator: Atherectomy<br>Atherectomy group | Device: plaque excision system<br>* plaque excision system<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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stent, atherectomy, iliac Artery