Oslo Balloon Angioplasty Versus Conservative Treatment

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

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Key information

Conditions

Peripheral Vascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

Up to 75 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle, PTA

Procedure

Primary outcomes

The patient quality of life.

Secondary outcomes

Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

Pfizer
University Hospital, Aker

Registry information

Important dates

Study start: 2000
Study completion: 2004
First posted: Sep 22, 2005
Registry last updated: Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed