NCT05117515

Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine

Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Vascular reconstruction	Vascular reconstructions in the carotid, profunda, femoral and iliac arteries

Timeline

• Start date: 2022-04-27
• Primary completion: 2024-11-27
• Completion: 2025-11-27
• First posted: 2021-11-11
• Last updated: 2025-12-16

Locations

1 site across 1 country: Germany