Prospective and Non-randomized Registry of CardioCel 3D

Great Vessel Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04175327
• Other study ID #: GLRA-G010
• Status: Recruiting
• Start date: August 28, 2020
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: LeMaitre Vascular
• Contact: Marit Balder
• Phone: +31 30 229 2727
• Email: marit.balder[@]avaniaclinical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 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. The CardioCel 3D Registry will collect data on the use of the CardioCel,

CardioCel Neo and CardioCel 3D for the following major indications:

• Intracardiac and septal defects

• Valve and annulus repair

• 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 devices' 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2026
• Est. primary completion date: November 2025
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient has signed the informed consent

• patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.

Exclusion Criteria:

• no study specific exclusion criteria; patients treated per standard clinical practice

Related Conditions & MeSH terms

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

Intervention

Device:
• CardioCel implantation
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Locations

Country	Name	City	State
Germany	Heart Center Leipzig	Leipzig
Italy	Policlinico San Donato	San Donato Milanese	MI
Italy	A.O.U. Città della Salute e della Scienza	Turin
Spain	Hospital Universitario "Doce de Octubre"	Madrid
United Kingdom	Bristol Children's Hospital and the Heart Institute	Bristol
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
LeMaitre Vascular	Factory CRO for Medical Devices B.V.

Countries where clinical trial is conducted

Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of graft related reintervention	capture the rate of graft related reintervention	30 days post procedure.
Primary	Incidence of patch related morbidity	capture the rate of patch related morbidity	30 days post procedure
Secondary	Incidence of graft related reinterventions	capture the rate of graft related reinterventions	at 1 and 2 years post-procedure
Secondary	Rates of Valvular Regurgitation Grade > Moderate	for Valve and annulus repair	30 days post procedure
Secondary	Rates of re-stenosis	for Great vessel reconstruction	at 30 days and 1 and 2 years follow-up
Secondary	Rates of recoarctation	for Great vessel reconstruction	at 30 days and 1 and 2 years follow-up
Secondary	Rates of measurement of the dynamic flow by facility standard of care =110-175* cm/sec for peripheral vascular locations	for Peripheral vascular reconstruction	at 30 days and 1 and 2 years follow-up
Secondary	incidence of Patch dehiscence	capturing the rate of patch dehiscence	at 30 days and 1 and 2 years follow-up
Secondary	Incidence of Patch calcification	capturing the rate of patch calcification	at 30 days and 1 and 2 years follow-up
Secondary	Incidence of Patch retraction	capturing the rate of patch retraction	at 30 days and 1 and 2 years follow-up
Secondary	Incidence of Unanticipated events	capturing the rate of unanticipated events	at 30 days and 1 and 2 years follow-up