Post-Market Registry in Europe and US for the Use of VascuCelTM
VascuCel
1 other identifier
observational
100
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMarch 10, 2025
March 1, 2025
2.3 years
May 25, 2021
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of graft related reintervention
collect data on the number of incidence of graft related reintervention
30 days post procedure.
Incidence of patch related morbidity
collect data on patch related morbidity
30 days post procedure.
Secondary Outcomes (7)
Incidence of graft related reintervention
at 1 and 2 years post procedure.
Rates of restenosis
at 30 days and 1 and 2 years follow-up
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
incidence of Patch dehiscence
at 30 days and 1 and 2 years follow-up
incidence of Patch calcification
at 30 days and 1 and 2 years follow-up
- +2 more secondary outcomes
Interventions
VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Eligibility Criteria
VascuCel is indicated for the repair of vascular defects including great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
You may qualify if:
- patient has signed the informed consent
- patient is a candidate for treatment with VascuCel per approved device indications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LeMaitre Vascularlead
- Avaniacollaborator
Study Sites (5)
Kootenai Health
Coeur d'Alene, Idaho, 83814, United States
Eddy Luh
Las Vegas, Nevada, 27599, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
University North Carolina
Chapel Hill, North Carolina, 27599, United States
ASST Sette Laghi Varese
Varese, 21100, Italy
Study Officials
- STUDY DIRECTOR
Ioana Ghiu
Anteris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
June 9, 2023
Primary Completion
October 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
March 10, 2025
Record last verified: 2025-03