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

Aesculap

Status: Invitation-only

Conditions: Carotid Artery Stenosis; Femoral Artery Stenosis; Iliac Artery Stenosis

Treatments: Device: Vascular reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT05117515

AAG-O-H-2116

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Uni-Graft KDV Patch

Treatment:

Device: Vascular reconstruction