Oslo Balloon Angioplasty Versus Conservative Treatment

Ullevaal University Hospital200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Peripheral Vascular Disease

Interventions

Eligibility

Sex: ALLMax age: 75 Days

Medical Language ↔ Plain English

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

Oslo Balloon Angioplasty Versus Conservative Treatment

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes