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Evaluation of acute and long-term outcomes after implantation of a supera stent in the femoropopliteal artery

Evaluation of acute and long-term outcomes after implantation of a supera stent in the femoropopliteal artery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031244
Enrollment
800
Registered
2023-02-13
Start date
2022-03-14
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: Single arm monocentric retrospective data analysis of patients after supera stent implantation of the femoropopliteal arteries. Follow-up up to 5 years after stent implantation

Sponsors

Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg
Lead Sponsor

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. Stenosis (=70% diameter reduction) or occlusion in the femoropopliteal vessel segment confirmed by duplex sonography and/or angiography. At least one follow-up examination (including duplex sonography and/ or angiography), in a period of at least 12 months after re-intervention.

Exclusion criteria

Exclusion criteria: Patients with stage 6 PAOD according to Rutherford-Becker classification. No relevant stenosis of the target lesion (<70% diameter reduction). 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

MeasureTime frame
Pimary patency- and Target-Revascularisation rate in a follow-up period of at least 12-50 months

Secondary

MeasureTime frame
Time to first TLR Minor and/or major amputation on the treated leg in the follow-up period. Amputation free survival Change in clinical symptoms according to the Rutherford-Becker classification Severe cardiovascular events (myocardial infarction, stroke, major amputation, death) in the follow-up period 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