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Evaluation of acute and long-term results of endovascular therapy for restenosis of the popliteal artery.

Evaluation of acute and long-term results of endovascular therapy for restenosis of the popliteal artery.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024582
Enrollment
150
Registered
2021-02-19
Start date
2021-02-16
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

I70.20

Interventions

Group 1: retrospective analysis of patients with re-stenosis popliteal

Sponsors

Universitäts-Herzzentrum Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactTanja Böhme

Universitäts-Herzzentrum Bad Krozingen

Tanja.Boehme@universitaets-herzzentrum.de004976334020

Outcome results

None listed

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