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临床试验/NCT06578741
NCT06578741
Enrolling By Invitation
不适用

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月25日最近更新:

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

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

Other

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)

研究者

发起方
W.L.Gore & Associates
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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