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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction or suture line buttressing. This registry will collect safety and performance data up to 2 years following implantation.
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of VascuCel in patients with vascular disorders and in accordance with local standard of care. The Registry has been designed to collect data up to 2 years following implantation. The VascuCel Registry will collect data on the use of the VascuCel, for the following major indications:
As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess device's safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing | Device | VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of graft related reintervention | collect data on the number of incidence of graft related reintervention | 30 days post procedure. |
| Incidence of patch related morbidity | collect data on patch related morbidity | 30 days post procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of graft related reintervention | collect data on the number of graft related reintervention | at 1 and 2 years post procedure. |
| Rates of restenosis | collect rate of restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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VascuCel is indicated for the repair of vascular defects including great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
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| Name | Affiliation | Role |
|---|---|---|
| Ioana Ghiu | Anteris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kootenai Health | Coeur d'Alene | Idaho | 83814 | United States | ||
| Eddy Luh |
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| at 30 days and 1 and 2 years follow-up |
| Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular location | collect rate of measurement of the dynamic flow | at 30 days and 1 and 2 years follow-up |
| incidence of Patch dehiscence | collect rate of patch dehiscence | at 30 days and 1 and 2 years follow-up |
| incidence of Patch calcification | collect rate of patch calcification | at 30 days and 1 and 2 years follow-up |
| incidence of Patch retraction | collect rate of patch retraction | at 30 days and 1 and 2 years follow-up |
| incidence of unanticipated and rare events | collect rate of unanticipated and rare events | at 30 days and 1 and 2 years follow-up |
| Las Vegas |
| Nevada |
| 27599 |
| United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| ASST Sette Laghi Varese | Varese | 21100 | Italy |