Intermittent claudication (IC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rutherford category 1, 2, or 3 2. Maximum pain-free walking distance 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: maximum walking distance; Secondary: preference based utilities (EQ-5D and Rating Scale), health status QoL scores (SF-36 and VascuQol), ABI, maximum painless walking distance, clinical success, therapeutic and total costs, CVD risk factor score, number of events; all outcomes after 1-, 6-, and 12-months follow-up. | — |
Countries
Netherlands