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.
|Peripheral Arterial Disease||Procedure: Angioplasty with Zilver PTX Other: Best medical treatment Device: Zilver PTX||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)|
- Maximal walking distance [ Time Frame: 24 months ]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.
- Ankle brachial pressure indices [ Time Frame: 24 months ]a measure of the peripheral bloodpressure
- Quality of life [ Time Frame: 24 months ]Quality of life is evaluated by using questionnaires
- Cost of the treatment [ Time Frame: 24 months ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02033135
|Contact: Lise P Jørgensen, MD,||+45 3545 email@example.com|
|Contact: Torben V Schroeder, MD, MDSc|
|Copenhagen, Østerbro, Denmark, 2100|
|Contact: Lise Pyndt, MD +45 35457458 firstname.lastname@example.org|
|Sub-Investigator: Lise Pyndt, MD|
|Study Director:||Torben V Schroeder, MD, MDSc||Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark|