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

Active, not recruiting

• Conditions: Peripheral Vessel Reconstruction; Great Vessel Reconstruction; Suture Line Buttressing

• Registration Number: NCT04906824
• Lead Sponsor: LeMaitre Vascular

Brief 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.

Detailed Description

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of VascuCel in patients with vascular disorders and in accordance with local standard of care. The Registry has been designed to collect data up to 2 years following implantation. The VascuCel Registry will collect data on the use of the VascuCel, for the following major indications:

* 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 device's 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.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2023-06-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-10
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
incidence of unanticipated and rare events	at 30 days and 1 and 2 years follow-up	collect rate of unanticipated and rare events
incidence of Patch dehiscence	at 30 days and 1 and 2 years follow-up	collect rate of patch dehiscence
incidence of Patch retraction	at 30 days and 1 and 2 years follow-up	collect rate of patch retraction
Incidence of graft related reintervention	at 1 and 2 years post procedure.	collect data on the number of graft related reintervention
Rates of restenosis	at 30 days and 1 and 2 years follow-up	collect rate of restenosis
incidence of Patch calcification	at 30 days and 1 and 2 years follow-up	collect rate of patch calcification
Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular location	at 30 days and 1 and 2 years follow-up	collect rate of measurement of the dynamic flow

Trial Locations

Locations (5)

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