Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
NCT05117515 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2025-12-16
Summary
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.
Conditions
- Femoral Artery Stenosis
- Iliac Artery Stenosis
- Carotid Artery Stenosis
Interventions
- DEVICE
-
Vascular reconstruction
Vascular reconstructions in the carotid, profunda, femoral and iliac arteries
Sponsors & Collaborators
-
Aesculap AG
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-27
- Primary Completion
- 2024-11-27
- Completion
- 2025-11-27
Countries
- Germany
Study Locations
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