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

NCT05117515 | Completed

• 1 other identifier: AAG-O-H-2116
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Artery Stenosis; Iliac Artery Stenosis; Carotid Artery Stenosis

Keywords

Reconstructive interventions; vascular patch; polyethylene terephthalate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative bleeding

  approximately up to 3 months after Implantation

• Rate of Intraoperative stroke

  intraoperatively

• Rate of postoperative stroke

  approximately up to 3 months after Implantation

• Rate of patch related infections

  approximately up to 3 months after Implantation

• Rate of postoperative nerve lesions

  approximately up to 3 months after Implantation

Study Arms (1)

Uni-Graft KDV Patch

Device: Vascular reconstruction

Interventions

Vascular reconstruction DEVICE

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

Uni-Graft KDV Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: April 27, 2022
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

DE (1)