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Adult Trials: 18+ Years
- Age below 75 years
- Symptoms of intermittent claudication with duration > 3 months
- ABPI <0.9
- A two-year follow-up is possible
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Oslo Balloon Angioplasty Versus Conservative Treatment | |||
| Official Title ICMJE | Oslo Balloon Angioplasty Versus Conservative Treatment | |||
| 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 | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Peripheral Vascular Disease | |||
| Intervention ICMJE | Procedure: lifestyle, PTA | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 200 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | December 2004 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
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| Ages ICMJE | up to 75 Days (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00222196 | |||
| Other Study ID Numbers ICMJE | OBACT | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Ullevaal University Hospital | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
| |||
| PRS Account | Oslo University Hospital | |||
| Verification Date | September 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||