DISSECT-N (Dissection Navion Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 22
- 主要终点
- Composite safety and effectiveness
研究概览
简要总结
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
详细描述
DISSECT-N is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
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
- •Subject is ≥18 years old
- •Subject was treated in the last 7 days, or is intended to be treated, with the Valiant Navion Thoracic Stent Graft System for a dissection in the thoracic aorta
- •Subject is willing to comply with standard of care clinical follow-up
- •Subject or legal representative or consultee, as applicable has consented for study participation and signed the approved Informed Consent
排除标准
- •Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study.
- •Subject is pregnant (not an exclusion if allowed per local regulatory requirements, pregnancy test to be performed where required)
- •Subject has an active COVID-19 infection or relevant history of COVID-
- •Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-
- •Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment.
结局指标
主要结局
Composite safety and effectiveness
时间窗: 1-month post index procedure
Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure. Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the delivery system. The primary endpoint is a dichotomous study outcome and a composite endpoint. A subject who has technical success and no MAE reported within 1-month will be considered a success.
次要结局
- Aortic remodeling(1-month, 1, 2 and 3 years)
- Stent induced entry tear(1, 2 and 3 years)
- Stent graft migration(1, 2 and 3 years)
- Transient Ischemic Attack (TIA)/minor strokes(1-month)
- Endoleaks(1-month, 1, 2 and 3 years)
- Access related complications(peri-operative)
- Unplanned secondary procedures(1, 2 and 3 years)
- False lumen perfusion(1-month, 1, 2 and 3 years)
- Disease progression(1,2 and 3 years)
- Transient spinal cord ischemia(1-month, 1, 2 and 3 years)
- Major adverse events(1, 2 and 3 years)
- Stent graft integrity(1-month, 1, 2 and 3 years)