Peripheral Arterial Disease, Intermittent claudication, Endovascular revascularization, Supervised exercise
Conditions
Interventions
1. Intervention group: Endovascular revascularization plus supervised exercise
2. Control group: Supervised exercise.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rutherford category 1, 2, or 3 (> 3 months duration); 2. ABI 0.15 after treadmill test; 3. Maximum walking distance 50% diameter reduction at the iliac or femoro-popliteal level; 5. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Lesions deemed unsuitable for revascularization; 2. Abdominal aortic aneurysm >5 cm or iliac aneurysm >1.5 cm; 3. Life-incapacitating cardiac disease (NYHA classification III and higher); 4. Prior treatment for the same lesion (including exercise training); 5. Contra indication for revascularization (allergy to iodinated contrast); 6. Ambulation limited by co-morbid condition; 7. Inability to walk on a tredamill without grade at a speed of at least 3.2 km/h for at least 2 minutes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum walking distance. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Preference based utilities (EQ-5D and Rating Scale); 2. Health status QoL scores (SF-36 and VascuQol); 3. ABI; 4. Maximum painless walking distance; 5. Clinical success; 6. Therapeutic and total costs; 7. CVD risk factor score; 8. Number of events. | — |
Contacts
Public ContactS. Spronk
Ikazia Hospital, Department of Surgery, Montessoriweg 1
Outcome results
None listed