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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028000

Enrollment

1133

Registered

2023-02-08

Start date

2022-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I70.22

Interventions

Group 1: Retrospective monocentric analysis of recanalisation of the femoropopliteal and infrapopliteal arteries using the antegrade retrograde technique in case of chronic total occlusions. It is a

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Success of the procedure using the retrograde puncture and recanalisation technique of the femoropopliteal and infrapopliteal arteries.	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactThomas Zeller

Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg

thomas.zeller@uniklinik-freiburg.de076334022431

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026