NCT02380716已完成不适用
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- All Cause Mortality at 30 Days Post-procedure
研究概览
简要总结
Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
详细描述
This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.
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
- •DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:
- •Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia
- •Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm
- •Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
- •High surgical risk, as determined by the implanting physician
- •Adequate vascular access via transfemoral or retroperitoneal approach
- •An Informed Consent Form signed by Subject or legally authorized representative
- •Able to comply with protocol requirements including follow-up
排除标准
- •Planned aortic valve repair or replacement or coronary artery intervention within 30 days
- •Presence of mechanical heart valve in the aortic position
- •Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta
- •Aortic insufficiency grade 3+ or 4+
- •Known irreversible neurological injury
- •Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- •Participation in another drug or medical device study within 1 year of study enrollment
- •Known history of drug abuse
- •Pregnant female at time of informed consent signature
- •Body habitus or other medical condition which prevents adequate visualization of the aorta
- •Systemic infection that could increase the risk of endovascular graft infection
- •Previous thoracic aortic surgery
- •Life expectancy <12 months due to associated non-cardiac co-morbid conditions
- •Subject has known sensitivities or allergies to the device materials
- •Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- •Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
研究组 & 干预措施
GORE® Ascending Stent Graft
Experimental
Treatment with the GORE® Ascending Stent Graft
干预措施: GORE® Ascending Stent Graft (Device)
结局指标
主要结局
All Cause Mortality at 30 Days Post-procedure
时间窗: 30 days post-procedure
Number of subjects that die of any cause within 30 days post-procedure
次要结局
- Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months(30 days, 6 months, and 12 months post procedure)
- Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months(30 days, 6 months, and 12 months post procedure)
- Successful Dissection Treatment (Technical Success)(At removal of device deployment system, up to conclusion of procedure)
- Aorta-related Mortality(30 days post procedure)
- Endoleak Assessed Through 1 Month, 6 Months, and 12 Months(30 days, 6 months, and 12 months post procedure)
- Individual MACCE Components Through 30 Days, 6 Months, and 12 Months(30 days, 6 months, and 12 months post procedure)
研究者
研究点 (2)
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