I70.22
Conditions
Interventions
Group 1: Endovascular therapy (balloon angioplasty, stent angioplasty, drug-coated balloon angioplasty, drug-coated stent angioplasty, atherectomy) of arteriosclerotically caused stenosis of the popli
Sponsors
Universitäts-Herzzentrum Bad Krozingen
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: - Patients with peripheral arterial occlusive disease in clinical stage 1-3 according to Rutherford-Becker classification. - De-novo stenosis caused by arteriosclerotic disease (=70% diameter reduction) or occlusion of the popliteal artery, duplex sonographically and/or angiographically confirmed. - Stenosis or occlusion of the popliteal artery which not include the superficial femoral artery and/or the anterior tibial artery and/or the tibiofibular truncus. - At least one open, non-stenosed (=50% diameter reduction) lower leg artery on the study leg. - At least one follow-up examination (including duplex sonography) in a period of at least 12 months after the index procedure.
Exclusion criteria
Exclusion criteria: - Patients with PAD in stage 0, 4 - 6 according to Rutherford-Becker classification. - Stenosis or occlusion of the poplitea artery not due to arteriosclerotic causes. - No relevant stenosis of the target lesion (7mm) - Unsuccessful intervention of the target lesion (remaining residual stenosis =30%) - Re-stenosis or re-occlusion of the target lesion after previous surgical and/or endovascular therapy. - Treated target lesion of the poplitea artery extends to the superficial femoral artery and/or the antior tibial artery and/or the tibiofibular truncus. - Occlusion or relevant stenosis (>50% diameter reduction) of all lower leg arteries. - Limited renal function (creatinine =2.4mg/dl) or terminal renal insufficiency requiring dialysis during index procedure. - No follow-up imaging (duplex sonography or angiography) of the target lesion at least 12 months after the index procedure (lost-to-follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from target lesion revascularization (TLR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Patency rate of the target lesion - Time to first re-intervention at the target lesion. - Minor and/or major amputation of the treated leg - Leg survival rate - Change in clinical symptoms based on the Rutherford-Becker classification. - Severe cardiovascular events (myocardial infarction, stroke, major amputation, death) | — |
Countries
Germany
Contacts
Public ContactThomas Zeller
Universitäts-Herzzentrum Bad Krozingen
Outcome results
None listed