Great Vessel ReconstructionVascuCelNCT04906824
Post-Market Registry in Europe and US for the Use of VascuCelTM
An observational study of Great Vessel Reconstruction and Peripheral Vessel Reconstruction, run by LeMaitre Vascular at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- What is being tested?
- great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 9 Jun 2023to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VascuCel is indicated for the repair of vascular defects including great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
Who may be able to join
- patient has signed the informed consent
- patient is a candidate for treatment with VascuCel per approved device indications.
Who cannot join
- no study specific exclusion criteria; patients treated per standard clinical practice
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University North Carolina
Chapel Hill, North Carolina, 27599
Kootenai Health
Coeur d'Alene, Idaho, 83814
Eddy Luh
Las Vegas, Nevada, 27599
Westchester Medical Center
Valhalla, New York, 10595
About this study
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.
Read the 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.
- Being tested
- great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
great vessel reconstruction; peripheral vascular reconstruction; suture line buttressingDevice
VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of graft related reintervention
collect data on the number of incidence of graft related reintervention
Measured: 30 days post procedure.
Incidence of patch related morbidity
collect data on patch related morbidity
Measured: 30 days post procedure.
Secondary outcomes (7)
Incidence of graft related reintervention
collect data on the number of graft related reintervention
Measured: at 1 and 2 years post procedure.
Rates of restenosis
collect rate of restenosis
Measured: 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
Measured: at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
collect rate of patch dehiscence
Measured: at 30 days and 1 and 2 years follow-up
incidence of Patch calcification
collect rate of patch calcification
Measured: at 30 days and 1 and 2 years follow-up
incidence of Patch retraction
collect rate of patch retraction
Measured: at 30 days and 1 and 2 years follow-up
incidence of unanticipated and rare events
collect rate of unanticipated and rare events
Measured: at 30 days and 1 and 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start9 Jun 2023
- Primary completionOct 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Great Vessel ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Ioana Ghiu, Study director, Anteris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906824
- Sponsor's protocol ID
- GLRA-G011
- Acronym
- VascuCel
- Status last verified
- Mar 2025
- First submitted
- 25 May 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry in Europe and US for the Use of VascuCelTM
- ClinicalTrials.gov ID
- NCT04906824
- Acronym / sponsor ID
- VascuCel / GLRA-G011
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VascuCel is indicated for the repair of vascular defects including great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
Key inclusion criteria (2 listed)
- patient has signed the informed consent
- patient is a candidate for treatment with VascuCel per approved device indications.
Key exclusion criteria (1 listed)
- no study specific exclusion criteria; patients treated per standard clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| great vessel reconstruction; peripheral vascular reconstruction; suture line buttressingVascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing | Device | – |
Primary outcome
Incidence of graft related reintervention
Time frame: 30 days post procedure.
collect data on the number of incidence of graft related reintervention
Incidence of patch related morbidity
Time frame: 30 days post procedure.
collect data on patch related morbidity
7 secondary outcomes
Incidence of graft related reintervention
Time frame: at 1 and 2 years post procedure.
Rates of restenosis
Time frame: 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
Time frame: at 30 days and 1 and 2 years follow-up
incidence of Patch dehiscence
Time frame: at 30 days and 1 and 2 years follow-up
incidence of Patch calcification
Time frame: at 30 days and 1 and 2 years follow-up
incidence of Patch retraction
Time frame: at 30 days and 1 and 2 years follow-up
incidence of unanticipated and rare events
Time frame: at 30 days and 1 and 2 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioana Ghiu study director
Anteris
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Great Vessel Reconstruction and Peripheral Vessel Reconstruction, run by LeMaitre Vascular at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of graft related reintervention (time frame: 30 days post procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.