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Oslo Balloon Angioplasty Versus Conservative Treatment

NCT00222196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-07-06

No results posted yet for this study

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

Conditions

  • Peripheral Vascular Disease

Interventions

PROCEDURE

lifestyle, PTA

Sponsors & Collaborators

  • University Hospital, Aker

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Marthe Nylaende, MD · Aker and Ullevål University Hospitals, Oslo, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Completion
2004-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00222196 on ClinicalTrials.gov