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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uni-Graft KDV Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular reconstruction | Device | Vascular reconstructions in the carotid, profunda, femoral and iliac arteries |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Only patients with an age ≥ 18 years at intervention, who had provided written informed consent and had been treated with Uni-Graft® K DV Patch will be eligible for documentation in this NIS. Patients who had received Uni-Graft® K DV Patch not for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery will be not included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |