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

• Sponsor: Aesculap AG (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05117515
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 5.2
• Patients Per Site Per Month: 38.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Artery Stenosis; Iliac Artery Stenosis; Carotid Artery Stenosis	Device: Vascular reconstruction

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Monocentric, Observational PMCF - Study on the Performance and Safety of Uni-Graft® K DV Patch in Patients With Vascular Reconstructions
• Actual Study Start Date: Apr 27, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Rate of Intraoperative stroke [intraoperatively]

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Düsseldorf	Düsseldorf	Nordrhein-Westfalen	Germany	40225

Sponsors and Collaborators

• Aesculap AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aesculap AG
• ClinicalTrials.gov Identifier: NCT05117515
• Other Study ID Numbers: AAG-O-H-2116
• First Posted: Nov 11, 2021
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aesculap AG: Reconstructive interventions; vascular patch; polyethylene terephthalate
• Additional relevant MeSH terms: Carotid Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Jun 21, 2022