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

• Conditions: Carotid Artery Stenosis; Iliac Artery Stenosis; Femoral Artery Stenosis
• Interventions: Device: Vascular reconstruction

• Registration Number: NCT05117515
• Lead Sponsor: Aesculap AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-11
• Study Start: 2022-04-27
• Status Verified: 2024-11
• Primary Completion: 2024-11-27
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uni-Graft KDV Patch	Vascular reconstruction	-

Primary Outcome Measures

Name	Time	Method
Restenosis Rate in postoperative Course	approximately up to 3 months after Implantation	Retrospective evaluation of restenosis rate from information documented in the patient file: the NASCET is an angiographic measurement recommended by the "North American Symptomatic Carotid Endarterectomy Trial"-Group. According to the NASCET-Method the grade of stenosis in relation to the diameter of the ACI distal to the stenosis in the area of the parallel arterial wall is measured.

Secondary Outcome Measures

Name	Time	Method
Rate of postoperative nerve lesions	approximately up to 3 months after Implantation	Retrospective evaluation of nerve lesion rate from information documented in the patient file: Report of any postoperative nerve lesions postoperative course
Rate of patch related infections	approximately up to 3 months after Implantation	Retrospective evaluation of any patch related infections from information documented in the patient file: Report of any patch related infections during postoperative course
Rate of postoperative pseudoaneurysm	approximately up to 3 months after Implantation	Retrospective evaluation of pseudoaneurysm rate from information documented in the patient file: Report of any postoperative pseudoaneurysm during postoperative course
Rate of Intraoperative stroke	intraoperatively	Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke
Rate of postoperative stroke	approximately up to 3 months after Implantation	Retrospective evaluation of stroke rate from information documented in the patient file: Report of any stroke during postoperative course
Primary and secondary patency rate	approximately up to 3 months after Implantation	Retrospective evaluation of primary and secondary patency rate from information documented in the patient file during postoperative course
Postoperative bleeding	approximately up to 3 months after Implantation	Retrospective evaluation of restenosis rate from information documented in the patient file: Report of any bleeding during postoperative course
Freedom of re-intervention rate	approximately up to 3 months after Implantation	Retrospective evaluation of re-intervention rate from information documented in the patient file: Report of any re-intervention during postoperative course

Trial Locations

Locations (1)

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany