MedTrace Logo

Prospective and Non-randomized Registry of CardioCel 3D

NCT04175327 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-03-10

No results posted yet for this study

Summary

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care.

The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.

Conditions

  • Intracardiac and Septal Defects
  • Valve and Anulus Repair
  • Great Vessel Reconstruction
  • Peripheral Vessel Reconstruction
  • Suture Line Buttressing

Interventions

DEVICE

CardioCel implantation

treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Sponsors & Collaborators

  • Factory CRO for Medical Devices B.V.

    collaborator OTHER

  • LeMaitre Vascular

    lead INDUSTRY

Principal Investigators

  • Ioana Ghiu · Anteris

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2025-11-30
Completion
2026-03-31

Countries

  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT04175327 on ClinicalTrials.gov