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

NCT ID: NCT05117515

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2025-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Artery Stenosis Iliac Artery Stenosis Carotid Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Uni-Graft KDV Patch

Vascular reconstruction

Intervention Type DEVICE

Vascular reconstructions in the carotid, profunda, femoral and iliac arteries

Interventions

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Vascular reconstruction

Vascular reconstructions in the carotid, profunda, femoral and iliac arteries

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* written informed consent
* treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery

Exclusion Criteria

* Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known
* Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate).
* No use of Uni-Graft® K DV Patch
* Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2116

Identifier Type: -

Identifier Source: org_study_id