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Oslo Balloon Angioplasty Vers...

Oslo Balloon Angioplasty Versus Conservative Treatment

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2004-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lifestyle, PTA

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

75 Days

Eligible Sex

ALL

Accepts Healthy Volunteers