Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
Conditions
Brief summary
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.
Detailed description
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: * Great vessel reconstruction * Peripheral vascular reconstruction 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.
Interventions
DEVICEgreat vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Sponsors
Avania
LeMaitre Vascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patient has signed the informed consent * patient is a candidate for treatment with VascuCel per approved device indications.
Exclusion criteria
* no study specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of graft related reintervention | 30 days post procedure. | collect data on the number of incidence of graft related reintervention |
| Incidence of patch related morbidity | 30 days post procedure. | collect data on patch related morbidity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular location | at 30 days and 1 and 2 years follow-up | collect rate of measurement of the dynamic flow |
| incidence of Patch dehiscence | at 30 days and 1 and 2 years follow-up | collect rate of patch dehiscence |
| Incidence of graft related reintervention | at 1 and 2 years post procedure. | collect data on the number of graft related reintervention |
| incidence of Patch retraction | at 30 days and 1 and 2 years follow-up | collect rate of patch retraction |
| incidence of unanticipated and rare events | at 30 days and 1 and 2 years follow-up | collect rate of unanticipated and rare events |
| incidence of Patch calcification | at 30 days and 1 and 2 years follow-up | collect rate of patch calcification |
| Rates of restenosis | at 30 days and 1 and 2 years follow-up | collect rate of restenosis |
Countries
Italy, United States
Outcome results
None listed