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Oslo Balloon Angioplasty Versus Conservative Treatment

This study has been completed.

Sponsors and Collaborators: Ullevaal University Hospital
University Hospital, Aker
Pfizer
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00222196
  Purpose

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 Intervention
Peripheral Vascular Disease
Procedure: lifestyle, PTA

MedlinePlus related topics:   Angioplasty    Peripheral Vascular Diseases    Vascular Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Oslo Balloon Angioplasty Versus Conservative Treatment

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • The patient quality of life.

Secondary Outcome Measures:
  • Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers

Estimated Enrollment:   200
Study Start Date:   November 2000
Estimated Study Completion Date:   December 2004

  Eligibility
Ages Eligible for Study:   up to 75 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222196

Sponsors and Collaborators
Ullevaal University Hospital
University Hospital, Aker
Pfizer

Investigators
Principal Investigator:     Marthe Nylaende, MD     Aker and Ullevål University Hospitals, Oslo, Norway    
  More Information


Study ID Numbers:   OBACT
First Received:   September 13, 2005
Last Updated:   December 29, 2005
ClinicalTrials.gov Identifier:   NCT00222196
Health Authority:   Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:
atherosclerosis  
quality of life  
pain-score  
biomarkers  

Study placed in the following topic categories:
Atherosclerosis
Peripheral Vascular Diseases
Vascular Diseases
Quality of Life
Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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