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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05117515 on ClinicalTrials.gov