Carotid Artery Stenosis, Femoral Artery Stenosis, Iliac Artery Stenosis
Conditions
Keywords
Reconstructive interventions, vascular patch, polyethylene terephthalate
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.
Interventions
DEVICEVascular reconstruction
Vascular reconstructions in the carotid, profunda, femoral and iliac arteries
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Intraoperative stroke | intraoperatively | Retrospective evaluation of stroke rate from information documented in the patient file: Report of any intraoperative stroke |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed