A Phase 4 Observational Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting for Arterial Replacement or Reconstruction in Patients With Extremity Vascular Trauma
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Kaplan-Meier estimated Symvess secondary patency
研究概览
简要总结
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
The primary objective of the study is to determine Symvess secondary patency at 1 year.
Additional key secondary objectives, such as limb salvage, infection-free rate, primary patency, and safety, will also be assessed at 1 year.
All participants will receive Symvess. This is an open-label study and there is no comparator.
Participants will undergo surgery to repair an extremity arterial injury using Symvess. Participants will be asked to return at regular intervals up to 1 year post-implant to undergo imaging to assess Symvess patency, and for other standard clinical safety and efficacy assessments.
详细描述
A Phase 4, observational, multicenter, non-randomized, open-label post-marketing study in patients treated with commercially available Symvess for injuries to upper and lower extremities.
All eligible patients treated with Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI. Eligible patients will be adults suitable for treatment with Symvess as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
Patients will be implanted with a Symvess as an interposition replacement or bypass using standard vascular surgical techniques. At least one anastomosis should be distal to or within the Axillary artery if repair is in upper extremity and either distal to or within the Femoral artery, if repair is in lower extremity.
Patients with injuries limited to the vessels of the heart, head and neck area or exclusively within the torso are not eligible for the study.
Each patient will be followed for up to 12 months post implantation. Post-implant assessments include the following:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years old
- •Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI
- •Symvess implant is to be used to re-establish blood flow to one of the major extremity arteries (see Section 4.1 for examples of size appropriate vessels)
- •Although the proximal anastomosis may originate in the upper or lower torso region, the distal anastomosis must terminate in the extremity (e.g., below the inguinal crease for lower extremity, in the axillary or more distal in the upper extremity)
- •Patient or legal representative is able, willing, and competent to give informed consent.
- •Patient's life expectancy is at least 1 year based on the judgement of the Investigator
- •Patient must have a home or place of residence whereby he/she may be contacted and a support system which would make them suitable for this study of one year follow-up duration
- •Patient must have confirmed health insurance
排除标准
- •Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization
- •Patients lacking enough healthy muscle and/or soft tissue for adequate coverage of Symvess
- •Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up
- •a. Positive screen for illicit drugs (THC use is not exclusionary)
- •Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders)
- •Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up
- •Employee of the Sponsor or patient who is an employee or relative of the Investigator
研究组 & 干预措施
Symvess
Symvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury
干预措施: Acellular Tissue Engineered Vessel (Biological)
结局指标
主要结局
Kaplan-Meier estimated Symvess secondary patency
时间窗: 12 months
Time-to-event analysis estimating the long-term cumulative probabilities of maintaining Symvess secondary patency through the 12-month follow-up period evaluated across the entire study population.
次要结局
- Kaplan-Meier estimated limb salvage rate(12 months)
- Kaplan-Meier estimated Symvess infection-free rate(12 months)
- Kaplan-Meier estimated Symvess primary patency(12 months)
- Rate and frequency of Treatment Emergent Adverse Events(12 months)