Oslo Balloon Angioplasty Versus Conservative Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00222196
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 6, 2011
University Hospital, Aker
Information provided by:
Oslo University Hospital

September 13, 2005
September 22, 2005
July 6, 2011
November 2000
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The patient quality of life.
Same as current
Complete list of historical versions of study NCT00222196 on Archive Site
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Same as current
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Oslo Balloon Angioplasty Versus Conservative Treatment
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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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral Vascular Disease
Procedure: lifestyle, PTA
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2004
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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
Sexes Eligible for Study: All
up to 75 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
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Ullevaal University Hospital
  • University Hospital, Aker
  • Pfizer
Principal Investigator: Marthe Nylaende, MD Aker and Ullevål University Hospitals, Oslo, Norway
Oslo University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP