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Oslo Balloon Angioplasty Versus Conservative Treatment

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

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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oslo Balloon Angioplasty Versus Conservative Treatment

Resource links provided by NLM:

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

Ages Eligible for Study:   up to 75 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00222196

Sponsors and Collaborators
Ullevaal University Hospital
University Hospital, Aker
Principal Investigator: Marthe Nylaende, MD Aker and Ullevål University Hospitals, Oslo, Norway
  More Information Identifier: NCT00222196     History of Changes
Other Study ID Numbers: OBACT
Study First Received: September 13, 2005
Last Updated: July 3, 2011

Keywords provided by Oslo University Hospital:
quality of life

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases processed this record on May 25, 2017