Cryoplasty of the femoropopliteal arteries in patients with intermittent claudication compared with conventional angioplasty: a randomized study
Phase 4
Recruiting
- Conditions
- Atherosclerotic occlusive disease. Vessel occlusion.10003216
- Registration Number
- NL-OMON29719
- Lead Sponsor
- Albert Schweitzer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients with intermittent claudication or critical ischemia with occlusive disease of the femoropopliteal arteries, where conservative treatment is ineffective.
Exclusion Criteria
Adverse effects of contrast agents in the past
Expected lifespan less than one year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>12 months patency of cryoplasty and PTA. No reintervention, no amputation, no<br /><br>significant restenosis or occlusion at duplex ultrasound</p><br>
- Secondary Outcome Measures
Name Time Method <p>Direct technical success (maximum of 30% stenosis), relief of symptoms,<br /><br>improvement in quality of life, complications of the procedure (< 24 hrs and <<br /><br>30 days). Complications include occlusion and thrombosis of the treated leg,<br /><br>distal emboli, death, stroke, myocardial infarction and acute surgical<br /><br>reintervention.</p><br>