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

Great Vessel Reconstruction Clinical Trial

— VascuCel  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906824
• Other study ID #: GLRA-G011
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: LeMaitre Vascular
• Contact: Marit Balder
• Phone: +31 30 229 2727
• Email: marit.balder[@]avaniaclinical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2026
• Est. primary completion date: October 2025
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Great Vessel Reconstruction
• Peripheral Vessel Reconstruction
• Suture Line Buttressing

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
LeMaitre Vascular	Avania

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

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