Fontaine II Peripheral arterial disease
Conditions
Interventions
One group of 200 patient will recieve supervised exercise therapy.
One group of 200 patients will recieve endovascular revascularization.
All patients will recieve optimal medical treatment.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Disabling claudication as defined by surgeon based on patient history. - Ankle/Brachial Index 0.15 after exercise test. - Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA (> 50% stenosis) or occlusion of the common or external iliac artery on Color Duplex Scanning (PSV 0 m/s) or on MRA - Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis > 50% by Color Duplex Scanning (PSV ratio >= 2.5 or EDV >= 0.6 m/s) or on MRA, or occlusion on DS (PSV 0 m/s) or MRA. - Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions. - Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline - The Maximum Walking Distance on a treadmill
Exclusion criteria
Exclusion criteria: - Life expectancy 150 micromol/l)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to assess the level of functional status following both treatments and to assess the cost-effectiveness and cost-utility of percutaneous revascularization from a societal perspective with supervised exercise therapy as the best alternative treatment available. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare initial PTA with supervised exercise therapy for patients with disabling intermittent claudication due to an iliac artery lesion with respect to patients* ability to walk and health related quality of life. | — |
Countries
Netherlands
Outcome results
None listed