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

Condition(s) studied

Investigational drug(s) / intervention(s)

great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing: VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (5)