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Oslo Balloon Angioplasty Versus Conservative Treatment

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Aker
Pfizer
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00222196
First received: September 13, 2005
Last updated: July 3, 2011
Last verified: September 2005

September 13, 2005
July 3, 2011
November 2000
Not Provided
The patient quality of life.
Same as current
Complete list of historical versions of study NCT00222196 on ClinicalTrials.gov Archive Site
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Disease
Procedure: lifestyle, PTA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2004
Not Provided

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
Both
up to 75 Days
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00222196
OBACT
Not Provided
Not Provided
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