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

NCT04906824 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-10

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • LeMaitre Vascular

    lead INDUSTRY

Principal Investigators

  • Ioana Ghiu · Anteris

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2025-10-31
Completion
2026-09-30

Countries

  • United States
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04906824 on ClinicalTrials.gov