Evaluation of the acute- and long-term results after endovascular therapy of the popliteal artery
- Conditions
- I70.22
- Registration Number
- DRKS00019096
- Lead Sponsor
- niversitäts-Herzzentrum Bad Krozingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 378
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.
- 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 (<70% diameter reduction).
- Ectasia or aneurysm of the poplitea artery (target lesion diameter >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).
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from target lesion revascularization (TLR)
- Secondary Outcome Measures
Name Time Method Secondary Patency rate of the target lesion - Time to first re-intervention at the target lesion. <br>- Minor and/or major amputation of the treated leg - Leg survival rate <br>- Change in clinical symptoms based on the Rutherford-Becker classification. <br>- Severe cardiovascular events (myocardial infarction, stroke, major amputation, death)