Intermittent Claudication
Conditions
Interventions
1. Intervention group: Percutaneous Transluminal Angioplasty
2. Control group: Supervised Exercise Therapy.
Sponsors
Academic Medical Center (AMC)
P.O. Box 22660
1100 DD Amsterdam
The Netherlands
+31 (0)20 5669111
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. Disabling claudication as defined by surgeon based on patient’s history; 3. Ankle/Brachial Index 0.15 after exercise test; 4. 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; 5. 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; 6. Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions; 7. Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline; 8. The Maximum Walking Distance on a treadmill < 300 meters.
Exclusion criteria
Exclusion criteria: 1. Life expectancy 150 micromol/l).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disease specific Quality of Life (VascuQoL); 2. Maximum Walking Distance (on a standardized treadmill test with a speed of 3.2 km/h at 10% incline after 1 year). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Painfree Walking Distance (on a standardized treadmill test with a speed of 3.2 km/h at 10% incline); 2. Functional Status ( ALDS); 3. Generic Quality of Life ( SF-36 and EQ5D); 4. Complications related to interventions; 5. Treatment failures; 6. Costs. | — |
Contacts
Public ContactF.A. Frans
Academisch Medisch Centrum Afdeling Vaatchirurgie/Interventieradiologie Meibergdreef 9
Outcome results
None listed