Evaluation of acute and long-term outcomes after complex combined antegrade/retrograde recanalisation technique for occlusions of the femoropopliteal and infrapopliteal arteries

• Conditions: I70.22

• Registration Number: DRKS00028000
• Lead Sponsor: niversitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-08
• Study Completion: 2023-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1133

Inclusion Criteria

Patients with peripheral arterial disease (CAD) in clinical stage 1-5 according to Rutherford-Becker classification.
Occlusion femoropopliteal and/or infrapopliteal arteries confirmed by duplex sonography and/or angiography.
At least one follow-up examination (including duplex sonography and/or angiography) within a period of at least 12 months after re-intervention.

Exclusion Criteria

Patients with stage 6 CAD according to Rutherford-Becker classification.
Endovascular therapy for stenosis.
No follow-up examinations (including duplex sonography) of the target lesion available for 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
Success of the procedure using the retrograde puncture and recanalisation technique of the femoropopliteal and infrapopliteal arteries.

Secondary Outcome Measures

Name	Time	Method
Revascularisation procedures (stent implantation, coated balloon angioplasty, thrombectomy, reentry device).<br>Periinterventional complication rate.<br>Haemostasis procedures of the retrograde puncture site at the distal thigh and lower leg.<br>Openness rate as well as re-intervention rate at the target lesion (target lesion revascularisation, TLR) in a follow-up period of at least 12 months after the index procedure.<br>Time to next re-intervention at the target lesion.<br>Minor and/or major amputation on the treated leg in the follow-up period.<br>Leg preservation rate during the follow-up period.<br>Change in clinical symptoms using the Rutherford-Becker classification (see appendix).<br>Serious cardiovascular events (myocardial infarction, stroke, major amputation, death) during the follow-up period after the index procedure.<br>Predictors for re-intervention