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Prospective and Non-randomized Registry of CardioCel 3D
Sponsor: LeMaitre Vascular
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.
Official title: Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2020-08-28
Completion Date
2026-03
Last Updated
2025-03-10
Healthy Volunteers
No
Conditions
Interventions
CardioCel implantation
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Locations (6)
Heart Center Leipzig
Leipzig, Germany
Policlinico San Donato
San Donato Milanese, MI, Italy
A.O.U. Città della Salute e della Scienza
Turin, Italy
Hospital Universitario "Doce de Octubre"
Madrid, Spain
Bristol Children's Hospital and the Heart Institute
Bristol, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom