Oslo Balloon Angioplasty Versus Conservative Treatment

Ullevaal University Hospital

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Procedure: lifestyle, PTA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00222196

OBACT

Details and patient eligibility

About

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

Sex: All

Ages: Under 75 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)