Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 20
- 主要终点
- Number of Subjects With Procedural Technical Success
研究概览
简要总结
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
详细描述
This is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Signed informed consent form
- •Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
- •Surgical indication for TEVAR based on investigator's best medical judgment
- •Intent to treat with CTAG Device with ACTIVE CONTROL.
排除标准
- •Paraplegia or paraparesis at initial presentation
- •Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
- •Prior implantation of a thoracic stent graft
- •Pregnant or breast-feeding female at time of informed consent signature
- •Life expectancy < 1 year due to comorbidities
结局指标
主要结局
Number of Subjects With Procedural Technical Success
时间窗: 24 hours
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Number of Subjects With Treatment Success at 30 Day Visit
时间窗: One month
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
次要结局
- Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion(One year)
- Number of Subjects With Freedom From Major Adverse Events at 12 Months(12 Months)
- Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events(Days 30, 365, and 455)
- Change in Maximum Aortic Diameter Among Dissection(One year)
- Change in Minimum True Lumen Diameter Among Dissection(One year)
- Number of Subjects With Freedom From Major Adverse Events at 30 Days(30 Days)
- Change in Maximum False Lumen Diameter Among Dissection(One year)
- Number of Subjects With Treatment Success at 12 Month Visit(One year)