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CompletedNCT00222196Updated Jul 6, 2011

Oslo Balloon Angioplasty Versus Conservative Treatment

An interventional study of lifestyle, PTA in Peripheral Vascular Disease, sponsored by Ullevaal University Hospital. Completed. Open to participants aged Up to 75 Days. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by Ullevaal University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
Up to 75 Days
Sex
All
01

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

02

Conditions studied

  • Peripheral Vascular Disease

Keywords

  • atherosclerosis
  • quality of life
  • pain-score
  • biomarkers
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 200 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Ullevaal University Hospital is the lead sponsor of 76 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants

Interventions

  • Procedurelifestyle, PTA
06

What researchers measure

Primary outcomes

  1. The patient quality of life.

Secondary outcomes

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00222196
Lead sponsor
Ullevaal University Hospital
Collaborators
University Hospital, Aker, Pfizer
First posted
Sep 22, 2005
Start date
Nov 2000
Completion
Dec 2004
Last update
Jul 6, 2011

Study contacts

Marthe Nylaende, MD
principal investigator · Aker and Ullevål University Hospitals, Oslo, Norway
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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