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Prospective and Non-randomized Registry of CardioCel 3D

← catalyst calendar

NCT04175327

Sponsored by LeMaitre Vascular (industry) · LMAT — their whole pipeline →. With Factory CRO for Medical Devices B.V..

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
200estimated
Sites
6
Countries
Germany, Italy, Spain +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-08-28actualWhen the study began enrolling
Primary completionNov 2025estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionMar 2026estimatedThe whole study's end, after follow-up
First posted2019-11-25actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-03-10actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Intervention

  • Device: CardioCel implantation

Primary outcomes

what the primary-completion date above is the date OF
Incidence of graft related reintervention
measured 30 days post procedure.
Incidence of patch related morbidity
measured 30 days post procedure

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