NCT04906824

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: LeMaitre Vascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Great Vessel Reconstruction
• Peripheral Vessel Reconstruction
• Suture Line Buttressing

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-09
• Primary completion: 2025-10-01
• Completion: 2026-09-01
• First posted: 2021-05-28
• Last updated: 2025-03-10

Locations

5 sites across 2 countries: United States, Italy