Cost-effectiveness of treatment strategies for intermittent claudicatio
Completed
- Conditions
- Intermittent claudication (IC)10003216
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
1. Rutherford category 1, 2, or 3
2. Maximum pain-free walking distance <350m
3. ABI <0.9 at rest or ABI decreasing by >0.15 after the treadmill test;
4. >=1 vascular stenoses of >50% diameter reduction at the iliac or femoro-popliteal level.
5. Informed consent
Exclusion Criteria
1. Abdominal aortic aneurysm
2. Life-incapacitating cardiac disease (NYHA classification III and higher);
3. Multilevel disease (i.e., same-side stenoses at both the iliac and femoral levels, requiring multiple revascularization procedures)
4. Isolated tibial artery disease
5. Lesions deemed unsuitable for revascularization
6. Prior treatment for the same lesion (including exercise training)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: maximum walking distance; Secondary: preference based utilities (EQ-5D<br /><br>and Rating Scale), health status QoL scores (SF-36 and VascuQol), ABI, maximum<br /><br>painless walking distance, clinical success, therapeutic and total costs, CVD<br /><br>risk factor score, number of events; all outcomes after 1-, 6-, and 12-months<br /><br>follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>