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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
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oslo Balloon Angioplasty Versus Conservative Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo 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

No publications provided

ClinicalTrials.gov Identifier: NCT00222196     History of Changes
Other Study ID Numbers: OBACT
Study First Received: September 13, 2005
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 21, 2013