Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
- 试验地点
- 74
- 主要终点
- Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
研究概览
简要总结
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
详细描述
For Zone 0/1, there are two arms (Aneurysm arm, Non-aneurysm arm) and three cohorts, described as follows: Zone 0/1 Aneurysm, Zone 0/1 Dissection, and Zone 0/1 Other Isolated Lesion. The Zone 0/1 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 0/1 Subjects enrolled for analysis were from the United States and Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-
- •Age ≥18 years at time of informed consent signature
- •Subject is capable of complying with protocol requirements, including follow-up
- •Informed Consent Form (ICF) is signed by Subject or legal representative
- •Must have appropriate proximal aortic landing zone.
- •Must have appropriate target branch vessel landing zone.
- •For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
- •Native aortic valve (Zone 0/1 subjects only)
- •Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)
排除标准
- •Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- •Previous endovascular repair of the ascending aorta
- •Previous endovascular repair of the DTA with a non-Gore device
- •Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access.
- •Infected aorta
- •Life expectancy <2 years
- •Myocardial infarction within 6 weeks prior to treatment
- •Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
- •Patient has a systemic infection and may be at increased risk of endovascular graft infection
- •Pregnant female at time of informed consent signature
- •Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- •Participation in another drug or medical device study within one year of study enrollment
- •Known history of drug abuse within one year of treatment
- •Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
- •Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- •Planned coverage of celiac artery
- •Patient has known sensitivities or allergies to the device materials
- •Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- •Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- •Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
- •Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
- •Mycotic aneurysm
- •Persistent refractory shock (systolic blood pressure <90 mm Hg)
- •Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
- •Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
- •Patient at high risk of neurological event, e.g. stroke
研究组 & 干预措施
Zone 0/1 Non-aneurysm aortic lesions
Includes dissection and other isolated lesion types
干预措施: GORE® TAG® Thoracic Branch Endoprosthesis (Device)
Zone 0/1 Non-aneurysm aortic lesions
Includes dissection and other isolated lesion types
干预措施: Revascularization Procedure (Procedure)
Zone 0/1 Aortic aneurysm
Zone 0/1 Aortic aneurysm
干预措施: GORE® TAG® Thoracic Branch Endoprosthesis (Device)
Zone 0/1 Aortic aneurysm
Zone 0/1 Aortic aneurysm
干预措施: Revascularization Procedure (Procedure)
结局指标
主要结局
Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
时间窗: 1 month
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1
时间窗: 12 months
Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
次要结局
未报告次要终点