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

Running, not enrolling

Conditions studied: Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing

In brief

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.

Key facts

Study ID

NCT04906824

Run by

LeMaitre Vascular

People needed

100

Starts

2023-06-09

Expected to finish

2026-09-01

Last updated by the study team

2025-03-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patient has signed the informed consent
• patient is a candidate for treatment with VascuCel per approved device indications.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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