GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- W.L.Gore & Associates
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Co-Primary Endpoint #2: Clinical Success
概览
简要总结
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
详细描述
A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.
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
- •The subject is / has:
- •Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
- •Age ≥18 years at the time of informed consent signature.
- •An Informed Consent Form signed by subject or legal representative.
排除标准
- •The subject is / has:
- •Any contraindications for the TAMBE Device according to the IFU.
- •Planned parallel grafting with the TAMBE Aortic Component.
- •Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
研究组 & 干预措施
Single Arm
Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
干预措施: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) (Device)
结局指标
主要结局
Co-Primary Endpoint #2: Clinical Success
时间窗: Index procedure through 12 months
All of the following qualifying criteria are met from the initiation of the index procedure through 12 months post-index procedure: * Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleak * Absence of lesion enlargement \>5 mm * Absence of device migration \>10 mm * Absence of failure due to device integrity issues (defined as Grade 2 or 3 in Table 8) * Absence of lesion rupture * Absence of conversion to open surgical repair * Absence of permanent paraplegia (see definition below) * Absence of disabling stroke (see definition below) * Absence of "loss of function" or "end-stage renal disease" stage according to the RIFLE Classification following the index procedure
Co-Primary Endpoint #1: Technical Success
时间窗: Time of index procedure
All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction): * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure. * Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography. * Absence of type I or type III endoleaks at final completion angiography. * Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
次要结局
- Secondary Patency(30 days, 6 months, annually through 10 years)
- Target Vessel Technical Success(30 days, 6 months, annually through 10 years)
- Intraprocedural Complications(30 days, 6 months, annually through 10 years)
- Secondary Clinical Success(30 days, 6 months, annually through 10 years)
- Thirty-Day Mortality(30 days)
- Target Vessel Instability(30 days, 6 months, annually through 10 years)
- Assisted Primary Clinical Success(30 days, 6 months, annually through 10 years)
- Lesion-Related Mortality(30 days, 6 months, annually through 10 years)
- Major Adverse Events (MAEs)(30 days, 6 months, annually through 10 years)
- Primary Patency(30 days, 6 months, annually through 10 years)
- Secondary interventions(Time of index procedure)
- Kink(30 days, 6 months, annually through 10 years)
- Stenosis(30 days, 6 months, annually through 10 years)
- Occlusion(30 days, 6 months, annually through 10 years)
- Primary Assisted Patency(30 days, 6 months, annually through 10 years)