CardioCel 3D Registry

• Research type

  Research Study

• Full title

  Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D

• IRAS ID

  272436

• Contact name

  Luisa Colombo Colombo

• Contact email

  lcolombo@admedus.com

• Sponsor organisation

  LeMaitre Vascular, Inc

• Clinicaltrials.gov Identifier

  NCT04175327

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  This is a European post-market, 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 has been designed to collect prospective product safety and performance data after the CardioCel line extension for CardioCel 3D and the indication expansion to include great vessel and peripheral reconstruction and suture line buttressing and will collect safety and performance data up to 2 years following implantation.

• REC name

  Wales REC 7

• REC reference

  20/WA/0028

• Date of REC Opinion

  17 Mar 2020

• REC opinion

  Further Information Favourable Opinion