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

Carotid Artery Stenosis Clinical Trial

— RESTUGPA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05117515
• Other study ID #: AAG-O-H-2116
• Status: Enrolling by invitation
• Start date: April 27, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Femoral Artery Stenosis
• Iliac Artery Stenosis

Intervention

Device:
• Vascular reconstruction
Vascular reconstructions in the carotid, profunda, femoral and iliac arteries

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of Intraoperative stroke	Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke	intraoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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