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Cost-effectiveness of treatment strategies for intermittent claudication: A Multicenter Randomized Controlled Trial.

Recruiting
Conditions
Peripheral Arterial Disease, Intermittent claudication, Endovascular revascularization, Supervised exercise
Registration Number
NL-OMON29241
Brief Summary

/A

Detailed Description

Not available

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
NameTimeMethod
Maximum walking distance.
Secondary Outcome Measures
NameTimeMethod
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.
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