Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis

Peripheral Arterial Disease Clinical Trial

— PESETA  

Official title:

Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02033135
• Other study ID #: H 4 2012 027
• Status: Recruiting
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: January 9, 2014
• Start date: June 2012
• Est. completion date: August 2017

Study information

• Verified date: January 2014
• Source: Rigshospitalet, Denmark
• Contact: Lise P Jørgensen, MD,
• Phone: +45 3545 3654
• Email: lpyndt[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ankle brachial pressure indices	a measure of the peripheral bloodpressure	24 months	Yes
Secondary	Quality of life	Quality of life is evaluated by using questionnaires	24 months	No
Secondary	Cost of the treatment		24 months	No