Post-Market Registry in Europe and US for the Use of VascuCelTM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-Market Registry in Europe and US for the Use of VascuCelTM

Conditions
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Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing

Intervention / Treatment
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* Device: great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria; patients treated per standard clinical practice
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing|VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |