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

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.

Study Overview

• Status: Recruiting
• Conditions: Great Vessel Reconstruction; Peripheral Vessel Reconstruction; Suture Line Buttressing
• Intervention / Treatment: Device: great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ioana Ghiu; Phone Number: 001 612 219 6032; Email: ighiu@anteristech.com
• Study Contact Backup: Name: Marit Balder; Phone Number: 1162 +31 30 229 2727; Email: marit.balder@avaniaclinical.com

Study Locations

• Italy
  • Varese, Italy, 21100
    • Not yet recruiting
    • ASST Sette Laghi Varese
    • Contact: Gabriele Piffaretti, Prof; Email: gabriele.piffaretti@uninsubria.it
• United States
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Recruiting
      • Kootenai Health
      • Contact: Elizabeth Brewer; Email: EBrewer@kh.org
  • Nevada
    • Las Vegas, Nevada, United States, 27599
      • Not yet recruiting
      • Eddy Luh
      • Contact: Eddy Luh; Email: drluh@lvsurgical.com
  • New York
    • Valhalla, New York, United States, 10595
      • Not yet recruiting
      • Westchester Medical Center
      • Contact: Romeo Mateo, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University North Carolina
      • Contact: Eric Cannon; Email: OSPContracting@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

VascuCel is indicated for the repair of vascular defects including great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of graft related reintervention	collect data on the number of graft related reintervention	at 1 and 2 years post procedure.
Rates of restenosis	collect rate 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	collect rate of measurement of the dynamic flow	at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence	collect rate of patch dehiscence	at 30 days and 1 and 2 years follow-up
incidence of Patch calcification	collect rate of patch calcification	at 30 days and 1 and 2 years follow-up
incidence of Patch retraction	collect rate of patch retraction	at 30 days and 1 and 2 years follow-up
incidence of unanticipated and rare events	collect rate of unanticipated and rare events	at 30 days and 1 and 2 years follow-up

Collaborators and Investigators

• Sponsor: LeMaitre Vascular
• Collaborators: Avania
• Investigators: Study Director: Ioana Ghiu, Anteris

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GLRA-G011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No