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Oslo Balloon Angioplasty Versus Conservative Treatment

Primary Purpose

Peripheral Vascular Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

lifestyle, PTA

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring atherosclerosis, quality of life, pain-score, biomarkers

Eligibility Criteria

undefined - 75 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

The patient quality of life.

Secondary Outcome Measures

Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers

Full Information

NCT ID

NCT00222196

First Posted

September 13, 2005

Last Updated

July 3, 2011

Sponsor

Ullevaal University Hospital

Collaborators

University Hospital, Aker, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00222196

Brief Title

Oslo Balloon Angioplasty Versus Conservative Treatment

Official Title

Oslo Balloon Angioplasty Versus Conservative Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

November 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ullevaal University Hospital

Collaborators

University Hospital, Aker, Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

Keywords

atherosclerosis, quality of life, pain-score, biomarkers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

lifestyle, PTA

Primary Outcome Measure Information:

Title

The patient quality of life.

Secondary Outcome Measure Information:

Title

Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Days

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marthe Nylaende, MD

Organizational Affiliation

Aker and Ullevål University Hospitals, Oslo, Norway

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Oslo Balloon Angioplasty Versus Conservative Treatment

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