Oslo Balloon Angioplasty Versus Conservative Treatment

NCT00222196

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Peripheral Vascular Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-75
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age below 75 years

- Symptoms of intermittent claudication with duration > 3 months

- ABPI <0.9

- A two-year follow-up is possible

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Peripheral Vascular DiseaseOslo Balloon Angioplasty Versus Conservative Treatment
NCT00222196
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
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, MDAker 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