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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05117515
Other study ID # AAG-O-H-2116
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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