Clinical trial NCT04906824: Post-Market Registry in Europe and US for the Use of VascuCelTM
Official title: Post-Market Registry in Europe and US for the Use of VascuCelTM
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Great Vessel Reconstruction
Peripheral Vessel Reconstruction
Suture Line Buttressing
Lead sponsor: LeMaitre Vascular
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2021-05-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of graft related reintervention
timeFrame: 30 days post procedure.
measure: Incidence of patch related morbidity
timeFrame: 30 days post procedure.
Secondary outcomes:
measure: Incidence of graft related reintervention
timeFrame: at 1 and 2 years post procedure.
measure: Rates of restenosis
timeFrame: at 30 days and 1 and 2 years follow-up
measure: Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular location
timeFrame: at 30 days and 1 and 2 years follow-up
measure: incidence of Patch dehiscence
timeFrame: at 30 days and 1 and 2 years follow-up
measure: incidence of Patch calcification
timeFrame: at 30 days and 1 and 2 years follow-up
measure: incidence of Patch retraction
timeFrame: at 30 days and 1 and 2 years follow-up
measure: incidence of unanticipated and rare events
timeFrame: at 30 days and 1 and 2 years follow-up
Other outcomes:
Locations:
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Las Vegas
country: United States
facility: Eddy Luh
state: Nevada
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University North Carolina
state: North Carolina
city: Varese
country: Italy
facility: ASST Sette Laghi Varese
Study officials:
affiliation: Anteris
name: Ioana Ghiu
role: STUDY_DIRECTOR
References: