A Prospective, Multi-center, Open-label Study, to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury When Autologous Vein Graft is Not Feasible.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Number of Participants with Treatment-Related Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss
- •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
- •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
- •Patient and parent/legal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits.
- •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
- •Life expectancy of at least 1 year based on clinical assessment by the Investigator
排除标准
- •Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7
- •Injury Severity Score (ISS) >60
- •Known pregnant females
- •Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
- •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS
- •Previous exposure to SYMVESS
- •Known participation in any investigational study within the last 30 days
- •Employees of the sponsor or patients who are employees or relatives of the Investigator
研究组 & 干预措施
Symvess
干预措施: Acellular Tissue Engineered Vessel (Symvess) (Biological)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events
时间窗: 12 months
Adverse Events including serious, events of special interest, and death will be assessed in the overall study population
Kaplan-Meier estimated patency
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点