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Trial record 1 of 1 for:    NCT00222196
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Oslo Balloon Angioplasty Versus Conservative Treatment

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.
 
ClinicalTrials.gov Identifier: NCT00222196
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 6, 2011
Sponsor:
Collaborators:
University Hospital, Aker
Pfizer
Information provided by:
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE November 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
The patient quality of life.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oslo Balloon Angioplasty Versus Conservative Treatment
Official Title  ICMJE Oslo Balloon Angioplasty Versus Conservative Treatment
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Disease
Intervention  ICMJE Procedure: lifestyle, PTA
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222196
Other Study ID Numbers  ICMJE OBACT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE
  • University Hospital, Aker
  • Pfizer
Investigators  ICMJE
Principal Investigator: Marthe Nylaende, MD Aker and Ullevål University Hospitals, Oslo, Norway
PRS Account Oslo University Hospital
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP