Clinical trial NCT02033135: Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis
Official title: Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Atherosclerosis
Intermittent claudication
Angioplasty
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maximal walking distance
timeFrame: 24 months
Secondary outcomes:
measure: Ankle brachial pressure indices
timeFrame: 24 months
measure: Quality of life
timeFrame: 24 months
measure: Cost of the treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark
name: Torben V Schroeder, MD, MDSc
role: STUDY_DIRECTOR
References: