Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Angioplasty with Zilver PTX; Other: Best medical treatment; Device: Zilver PTX

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Østerbro
    • Copenhagen, Østerbro, Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Lise Pyndt, MD; Phone Number: +45 35457458; Email: lpyndt@gmail.com
      • Sub-Investigator: Lise Pyndt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Director: Torben V Schroeder, MD, MDSc, Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Atherosclerosis; Angioplasty; Intermittent claudication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: H 4 2012 027