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

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis; Iliac Artery Stenosis; Femoral Artery Stenosis
• Intervention / Treatment: Device: Vascular reconstruction

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitätsklinikum Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Only patients with an age ≥ 18 years at intervention, who had provided written informed consent and had been treated with Uni-Graft® K DV Patch will be eligible for documentation in this NIS. Patients who had received Uni-Graft® K DV Patch not for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery will be not included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uni-Graft KDV Patch	Device: Vascular reconstruction; Vascular reconstructions in the carotid, profunda, femoral and iliac arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restenosis Rate in postoperative Course	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.	approximately up to 3 months after Implantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2025

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Reconstructive interventions; vascular patch; polyethylene terephthalate
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: AAG-O-H-2116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No