Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

Detailed Description
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The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern. Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.

Official Title
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Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Stenting (Smart Stent)
* Device: Stenting after PEB (Smart Stent, Invatec)
* Procedure: Atherectomy (SilverHawk device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6) Written informed consent Exclusion Criteria: Acute ischemia and/or acute thrombosis of the SFA Untreated ipsilateral iliac artery stenosis >70% Previous stenting of the SFA Popliteal stenosis >70% Severe renal insufficiency

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: Stenting<br>Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon. | Device: Stenting (Smart Stent)<br>* Nitinol stent<br>* Other names: Smart Stent, Cordis, Johnson & Johnson;|
| Experimental: Stenting after PEB<br>Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon. | Device: Stenting (Smart Stent)<br>* Nitinol stent<br>* Other names: Smart Stent, Cordis, Johnson & Johnson;Device: Stenting after PEB (Smart Stent, Invatec)<br>* Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).<br>* Other names: Smart Stent, Cordis, Johnson & Johnson;|
| Experimental: Atherectomy<br>The third randomization arm is Atherectomy. | Procedure: Atherectomy (SilverHawk device)<br>* Atherectomy<br>* Other names: SilverHawk device (EV3 Inc);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage diameter stenosis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 6 and 24 months | 
| Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) |  | 6 months | 
| Time to onset of any of MAPE. |  | 3-24 months | 
| Binary restenosis rate |  | 6 months | 
| Percentage diameter stenosis in duplex ultrasound |  | 6 and 24 months | 
| Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire) |  | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, atherectomy, paclitaxel-eluting balloon