Peripheral Arterial Disease
Conditions
Keywords
Atherosclerosis, Intermittent claudication, Angioplasty
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.
Interventions
PROCEDUREAngioplasty with Zilver PTX
Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)
OTHERBest medical treatment
Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.
DEVICEZilver PTX
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal walking distance | 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
| Measure | Time frame | Description |
|---|---|---|
| Ankle brachial pressure indices | 24 months | a measure of the peripheral bloodpressure |
| Quality of life | 24 months | Quality of life is evaluated by using questionnaires |
| Cost of the treatment | 24 months | — |
Countries
Denmark
Contacts
Primary ContactLise P Jørgensen, MD,
Backup ContactTorben V Schroeder, MD, MDSc
Outcome results
None listed