Oslo Balloon Angioplasty Versus Conservative Treatment

Peripheral Vascular Disease Clinical Trial

Official title:

Oslo Balloon Angioplasty Versus Conservative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222196
• Other study ID #: OBACT
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 3, 2011
• Start date: November 2000
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Procedure:
• lifestyle, PTA

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Pfizer, University Hospital, Aker

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patient quality of life.
Secondary	Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers