Arterial Bleeding, Arterial Injury, Vascular Trauma
Conditions
Keywords
Symvess, Trauma, Adolescents, Arterial injury
Brief summary
The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available. The main questions the study aims to answer are: Safety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free Participants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.
Detailed description
A prospective, multi-center, open-label study, to assess the safety and efficacy of SYMVESS® as a vascular conduit for repair of extremity arterial injury in adolescents (age 17 years or younger) who have reached adult sexual maturity (Tanner Sexual Maturity Rating Stage 5). Eligible participants will require urgent revascularization to avoid imminent limb loss, and autologous vein graft is not feasible. Participants will return for routine follow-up visits up to 12-months post implantation.
Interventions
BIOLOGICALAcellular Tissue Engineered Vessel (Symvess)
ATEV
Sponsors
Humacyte, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator a. For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends beyond the inguinal crease onto the thigh 2. Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss 3. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS per the judgment of the treating surgeon, taking into account vasoconstriction and situational inflow and outflow considerations 4. Autologous vein graft is either not feasible, in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit) or is not desirable because of the urgency of revascularization 5. Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits. 6. Patient is able and willing to provide informed assent and parent (or legal representative) is able and willing to provide informed consent prior to treatment with SYMVESS 7. Life expectancy of at least 1 year based on clinical assessment by the Investigator
Exclusion criteria
1. Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7 2. Injury Severity Score (ISS) \>60 3. Known pregnant females 4. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries 5. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS 6. Previous exposure to SYMVESS 7. Known participation in any investigational study within the last 30 days 8. Employees of the sponsor or patients who are employees or relatives of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | 12 months | Adverse Events including serious, events of special interest, and death will be assessed in the overall study population |
| Kaplan-Meier estimated patency | 12 months | Time-to-event analysis estimating the long-term cumulative probabilities of maintaining ATEV patency through the 12-month follow-up period, evaluated across the entire overall study population. |
| Kaplan-Meier estimated amputation-free rate | 12 months | Time-to-event analysis estimating the long-term cumulative probabilities of amputation-free ATEV rate through the 12-month follow-up period, evaluated across the entire overall study population. |
| Kaplan-Meier estimated infection-free rate | 12 months | Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free ATEV rates through the 12-month follow-up period, evaluated across the entire overall study population. |
Contacts
CONTACTWarren Prosser
Outcome results
None listed