Oslo Balloon Angioplasty Versus Conservative Treatment
Not Applicable
Completed
- Conditions
- Peripheral Vascular Disease
- Registration Number
- NCT00222196
- Lead Sponsor
- Ullevaal University Hospital
- Brief Summary
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.
The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.
Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Age below 75 years
- Symptoms of intermittent claudication with duration > 3 months
- ABPI <0.9
- A two-year follow-up is possible
Exclusion Criteria
- Subjective pain-free walking distance > 400m
- Critical ischemia
- Previous vascular or endovascular surgery
- Diabetes ulcer
- Other physical disability abrogating organised exercise
- Use of warfarin
- Mentally unable to give informed consent
- Renal insufficiency
- Coagulation disorders Duplex or PTA impossible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The patient quality of life.
- Secondary Outcome Measures
Name Time Method Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers