I70.20
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with peripheral arterial disease in clinical stage 1-4 according to Rutherford-Becker classification. Re-stenosis (=70% diameter reduction) or re-occlusion of the popliteal artery, confirmed by duplex sonography and/or angiography. Re-stenosis or re-occlusion of the popliteal artery must not involve the superficial femoral artery and/or the anterior tibial artery and/or the tibiofibular trunk. Have at least one open, nonstenosed (=50% diameter reduction) transtibial artery on the study leg. Have at least one follow-up (including duplex sonography and/ or angiography), in a period of at least 12 months after re-intervention.
Exclusion criteria
Exclusion criteria: Patients with pAVK stage 0, 5, 6 according to Rutherford-Becker classification. De novo stenosis or occlusion of the popliteal artery. No relevant stenosis of the target lesion (7mm) Re-stenosis after previous surgical therapy. Treated target lesion of popliteal artery extends to superficial femoral artery and/or anterior tibial artery and/or tibiofibular trunk. Occlusion or relevant stenosis (>50% diameter reduction) of all arteries of the lower leg. No follow-up examinations (including duplex sonography) of the target lesion available in a period of at least 12 months after the index procedure (lost-to-follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency rate as well as re-intervention rate at the target lesion ("target lesion revascularization", TLR) in a follow-up period of at least 12 months after the index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to next re-intervention at the target lesion. Minor and/or major amputation on the treated leg in the follow-up period. Change in clinical symptoms using the Rutherford-Becker classification (see Appendix). Serious cardiovascular events (myocardial infarction, stroke, major amputation, death) in the follow-up period after the index procedure. | — |
Countries
Germany
Contacts
Universitäts-Herzzentrum Bad Krozingen