Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracardiac and Septal Defects
- Sponsor
- LeMaitre Vascular
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Incidence of graft related reintervention
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of graft related reintervention
Time Frame: 30 days post procedure.
capture the rate of graft related reintervention
Incidence of patch related morbidity
Time Frame: 30 days post procedure
capture the rate of patch related morbidity
Secondary Outcomes
- Incidence of graft related reinterventions(at 1 and 2 years post-procedure)
- incidence of Patch dehiscence(at 30 days and 1 and 2 years follow-up)
- Rates of recoarctation(at 30 days and 1 and 2 years follow-up)
- Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations(at 30 days and 1 and 2 years follow-up)
- Incidence of Unanticipated events(at 30 days and 1 and 2 years follow-up)
- Rates of Valvular Regurgitation Grade > Moderate(30 days post procedure)
- Rates of re-stenosis(at 30 days and 1 and 2 years follow-up)
- Incidence of Patch calcification(at 30 days and 1 and 2 years follow-up)
- Incidence of Patch retraction(at 30 days and 1 and 2 years follow-up)