Peripheral Vascular Disease
Conditions
Keywords
atherosclerosis, quality of life, pain-score, biomarkers
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
Interventions
PROCEDURElifestyle, PTA
Sponsors
University Hospital, Aker
Pfizer
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Days
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patient quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers | — |
Outcome results
None listed