Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

Rigshospitalet

Status and phase: Unknown; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Device: Zilver PTX; Procedure: Angioplasty with Zilver PTX; Other: Best medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02033135

H 4 2012 027

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Angioplasty with Zilver PTX

Experimental group

Description:

Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy.

Treatment:

Device: Zilver PTX

Procedure: Angioplasty with Zilver PTX

Other: Best medical treatment

Best medical treatment

Active Comparator group

Description:

Unsupervised exercise therapy, smoking cessation advice and best medical therapy.

Treatment:

Other: Best medical treatment