Oslo Balloon Angioplasty Versus Conservative Treatment
|ClinicalTrials.gov Identifier: NCT00222196|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 6, 2011
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
|Condition or disease||Intervention/treatment|
|Peripheral Vascular Disease||Procedure: lifestyle, PTA|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oslo Balloon Angioplasty Versus Conservative Treatment|
|Study Start Date :||November 2000|
|Estimated Study Completion Date :||December 2004|
- The patient quality of life.
- Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222196
|Principal Investigator:||Marthe Nylaende, MD||Aker and Ullevål University Hospitals, Oslo, Norway|