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
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Oslo Balloon Angioplasty Versus Conservative Treatment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222196
|Principal Investigator:||Marthe Nylaende, MD||Aker and Ullevål University Hospitals, Oslo, Norway|