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Oslo Balloon Angioplasty Versus Conservative Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222196
First Posted: September 22, 2005
Last Update Posted: July 6, 2011
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.
Collaborators:
University Hospital, Aker
Pfizer
Information provided by:
Oslo University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00222196     History of Changes
Other Study ID Numbers: OBACT
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: July 6, 2011
Last Verified: September 2005

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