Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
研究概览
地位
详细说明
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Harrison Lead Clinical Study Manager
- 电话号码:12068225653
- 邮箱:hkelner@wlgore.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
The patient pool from which sites will screen for enrollment is comprised of patients with history of thoracic aortic disease that required surgical repair using a FET procedure. For qualifying patients with dissections, they will be enrolled into either of the following cohorts:
- Hyperacute: onset of symptoms must be documented to be <24 hours prior to the date of the procedure.
- Acute: onset of symptoms must be documented to be 1-14 days prior to the date of the procedure.
- Subacute: onset of symptoms must be documented to be 15-90 days prior to the date of the procedure.
- Chronic: onset of symptoms must be documented to be more than 90 days prior to the date of the procedure.
Those patients who meet all inclusion and no exclusion criteria, will be eligible for enrollment in this retrospective study.
描述
Inclusion Criteria:
- Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
- Age ≥ 18 years at the time of the index procedure.
- Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
- Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site.
Exclusion Criteria:
- Any modification performed on the CTAG Device, excluding suturing.
- Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
- Pregnant at the time of the index procedure.
- Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Chronic/Subacute Dissections and Aneurysms
|
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
|
|
Acute/Hyperacute Dissections
|
Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MAE freedom within one year (365 days) post-implant
大体时间:From date of index procedure through 365 days post implant
|
The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant:
|
From date of index procedure through 365 days post implant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Freedom from imaging outcomes within the 12-Month analysis window
大体时间:From the date of the index procedure through end of 12 months analysis window unless otherwise specified
|
The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified:
|
From the date of the index procedure through end of 12 months analysis window unless otherwise specified
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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