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Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02033135
Recruitment Status : Unknown
Verified January 2014 by Lise Pyndt Jørgensen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Angioplasty with Zilver PTX Other: Best medical treatment Device: Zilver PTX Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
Study Start Date : June 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ankle brachial pressure indices [ Time Frame: 24 months ]
    a measure of the peripheral bloodpressure

  2. Quality of life [ Time Frame: 24 months ]
    Quality of life is evaluated by using questionnaires

  3. Cost of the treatment [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033135


Contacts
Contact: Lise P Jørgensen, MD, +45 3545 3654 lpyndt@gmail.com
Contact: Torben V Schroeder, MD, MDSc

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Østerbro, Denmark, 2100
Contact: Lise Pyndt, MD    +45 35457458    lpyndt@gmail.com   
Sub-Investigator: Lise Pyndt, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Torben V Schroeder, MD, MDSc Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark
More Information

Responsible Party: Lise Pyndt Jørgensen, MD, Ph. D. student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02033135     History of Changes
Other Study ID Numbers: H 4 2012 027
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Lise Pyndt Jørgensen, Rigshospitalet, Denmark:
Atherosclerosis
Intermittent claudication
Angioplasty

Additional relevant MeSH terms:
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action