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Evaluation of acute and long-term outcomes of atherectomy in femoropoliteal and infrapopliteal lesions

Evaluation of acute and long-term outcomes of atherectomy in femoropoliteal and infrapopliteal lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031245
Enrollment
1200
Registered
2023-02-14
Start date
2021-03-22
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: Monocentric retrospective single-arm study to evaluate acute and longterm primary patency rate and target lesion re-intervention rate after atherectomy of the femoropopliteal and infrapoplit

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 (PAOD) in clinical stage 2-5 according to the Rutherford-Becker classification. Patients treated by atherectomy. Stenosis (=70% diameter reduction) or occlusion femoropopliteal or in the arteries of the lower leg. 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 PAOD who have not been treated with an atherectomy device. No follow-up (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
Primary patency rate and Target Lesion Revascularisation rate in a follow up period of at least 12 Months

Secondary

MeasureTime frame
Time to first re-intervention at the target lesion. Minor and/or major amputation on the treated leg in the follow-up period. Amputationfree survivale during the follow-up period. Presence of predictors of re-stenosis or re-intervention (risk factors, atherectomy preparation, lesion characteristics). Change in clinical symptoms according to the Rutherford-Becker classification Severe cardiovascular events (myocardial infarction, stroke, major amputation, death) in the follow-up period

Countries

Germany

Contacts

Public ContactThomas Zeller

Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg

thomas.zeller@universitaets-herzzentrum.de076334022431

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026