Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

Study Overview
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Brief Summary
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This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis. Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.

Official Title
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Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Angioplasty with Zilver PTX
* Other: Best medical treatment
* Device: Zilver PTX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has signed and dated the informed consent. Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria. Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm. Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open 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 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire) Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect. Patient has a resting ABI <0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a TBI <0.8. Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months. Exclusion Criteria: Patient is pregnant, breast-feeding or under 18 years of age. Patient unable to understand and sign informed consent forms Patient is simultaneously participating in another investigational drug or device study. Patient has any planned surgical or interventional procedure within 30 days after the study procedure. Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol. Patient 2-3 patent crural vessel runoff with <50% stenosis throughout its course. Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI > 40 Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angioplasty with Zilver PTX<br>Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy. | Procedure: Angioplasty with Zilver PTX<br>* Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)<br>Other: Best medical treatment<br>* Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.<br>Device: Zilver PTX<br> <br> |
| Active Comparator: Best medical treatment<br>Unsupervised exercise therapy, smoking cessation advice and best medical therapy. | Other: Best medical treatment<br>* Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal walking distance | Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle brachial pressure indices | a measure of the peripheral bloodpressure | 24 months | 
| Quality of life | Quality of life is evaluated by using questionnaires | 24 months | 
| Cost of the treatment |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Intermittent claudication, Angioplasty