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Clinical Trials in Italy / NCT04906824
Active, not recruiting Observational

Post-Market Registry in Europe and US for the Use of VascuCelTM

NCT04906824 · tracked via the Priya Life Science Italy tracker
Sponsor
LeMaitre Vascular
Phase
Observational
Started
2023-06-09
Last updated
2025-03-10

Condition(s) studied

Great Vessel ReconstructionPeripheral Vessel ReconstructionSuture Line Buttressing

Investigational drug(s) / intervention(s)

great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing: VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Study summary

This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction or suture line buttressing. This registry will collect safety and performance data up to 2 years following implantation.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patient has signed the informed consent * patient is a candidate for treatment with VascuCel per approved device indications. Exclusion Criteria: * no study specific exclusion criteria; patients treated per standard clinical practice

Primary outcome measure(s)

  • Incidence of graft related reintervention — 30 days post procedure.
    collect data on the number of incidence of graft related reintervention
  • Incidence of patch related morbidity — 30 days post procedure.
    collect data on patch related morbidity

Trial sites (5)

FacilityCityRegionStatus
Kootenai Health Coeur d'Alene Idaho
Eddy Luh Las Vegas Nevada
Westchester Medical Center Valhalla New York
University North Carolina Chapel Hill North Carolina
ASST Sette Laghi Varese Varese Italy

More LeMaitre Vascular trials in Italy

Prospective and Non-randomized Registry of CardioCel 3D Active, not recruiting

Other trials for the same condition

Prospective and Non-randomized Registry of CardioCel 3D Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04906824 on ClinicalTrials.gov ↗ ← All trials in Italy