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

Study Overview
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Brief Summary
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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.

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

Conditions
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Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis

Intervention / Treatment
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* Device: Vascular reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uni-Graft KDV Patch<br> | Device: Vascular reconstruction<br>* Vascular reconstructions in the carotid, profunda, femoral and iliac arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Rate of Intraoperative stroke | Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke | intraoperatively | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reconstructive interventions, vascular patch, polyethylene terephthalate