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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 主要终点
- MAE freedom within one year (365 days) post-implant
研究概览
简要总结
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure
详细描述
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •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.
排除标准
- •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.
结局指标
主要结局
MAE freedom within one year (365 days) post-implant
时间窗: 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: * Permanent Stroke * Permanent Paraplegia/ Paraparesis * Mortality * Reoperation
次要结局
- Freedom from imaging outcomes within the 12-Month analysis window(From the date of the index procedure through end of 12 months analysis window unless otherwise specified)