Cost-effectiveness of treatment strategies for intermittent claudication: A Multicenter Randomized Controlled Trial.
Recruiting
- Conditions
- Peripheral Arterial Disease, Intermittent claudication, Endovascular revascularization, Supervised exercise
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 210
Inclusion Criteria
1. Rutherford category 1, 2, or 3 (> 3 months duration);
2. ABI <0.9 at rest or ABI decreasing by >0.15 after treadmill test;
Exclusion Criteria
1. Lesions deemed unsuitable for revascularization;
2. Abdominal aortic aneurysm >5 cm or iliac aneurysm >1.5 cm;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum walking distance.
- Secondary Outcome Measures
Name Time Method 1. Preference based utilities (EQ-5D and Rating Scale);<br /><br>2. Health status QoL scores (SF-36 and VascuQol);<br /><br>3. ABI;<br /><br>4. Maximum painless walking distance;<br /><br>5. Clinical success;<br /><br>6. Therapeutic and total costs;<br /><br>7. CVD risk factor score; <br /><br>8. Number of events.