intermittent claudication peripheral arterial disease
Conditions
Interventions
Randomisation between Supera and Absolute Pro stenting
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - PAD (ABI 0.15 after exercise test), Rutherford category 2, 3 or 4 - Significant stenoses (* 50%) and/or occlusions in the superficial femoral artery and/or popliteal artery (P1) - Eligible for endovascular treatment according to international guidelines (with the expectation of stenting after PTA) - Adequate inflow (
Exclusion criteria
Exclusion criteria: - Patients with PAD Rutherford category 5 and 6 - Contralateral lesions that require treatment within 30 days before or after the procedure - Contra-indication for anticoagulant therapy - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Absence of binary restenosis (* 50% re-obstruction) of the target lesion as assessed by duplex ultrasound after 12 months without interval clinically driven reintervention - Number of clinically driven target lesion revascularisation within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in pain-free walking distance and absolute walking distance as assessed by standardized exercise test - Changes in quality of life as assessed by EuroQol 5 Demension (EQ-5D) questionnaire - Clinical complications (number of adverse events, serious adverse events and major adverse events) - Sustained clinical improvement as assessed by distribution of Rutherford stages - Procedural success (technical success, device success and procedural complications) | — |
Countries
Netherlands
Outcome results
None listed