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Completed

NCT Number: NCT05117515

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

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.

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Key information

Conditions

Femoral Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Artery Stenosis Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Iliac Artery Stenosis Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vascular reconstruction

Device

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

Primary outcomes

  1. Restenosis Rate in postoperative Course

    Time frame: 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 outcomes

  1. Postoperative bleeding

    Time frame: 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

  2. Rate of Intraoperative stroke

    Time frame: intraoperatively

    Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke

  3. Rate of postoperative stroke

    Time frame: 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

  4. Rate of patch related infections

    Time frame: 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

  5. Rate of postoperative nerve lesions

    Time frame: 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

  6. Rate of postoperative pseudoaneurysm

    Time frame: 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

  7. Primary and secondary patency rate

    Time frame: 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

  8. Freedom of re-intervention rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: RESTUGPA

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 11, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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