NCT00222196

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

July 6, 2011

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

July 3, 2011

Conditions

Peripheral Vascular Disease

Keywords

atherosclerosisquality of lifepain-scorebiomarkers

Outcome Measures

Primary Outcomes (1)

  • The patient quality of life.

Secondary Outcomes (1)

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

Interventions

lifestyle, PTAPROCEDURE

Eligibility Criteria

AgeUp to 75 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age below 75 years
  • Symptoms of intermittent claudication with duration \> 3 months
  • ABPI \<0.9
  • A two-year follow-up is possible

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Vascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Marthe Nylaende, MD

    Aker and Ullevål University Hospitals, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2000

Study Completion

December 1, 2004

Last Updated

July 6, 2011

Record last verified: 2005-09