Thoraflex Hybrid and Relay Extension Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 352
- 试验地点
- 39
- 主要终点
- Primary Safety Endpoint is a composite of the following:
研究概览
简要总结
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.
Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.
Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
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
- •Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.
- •Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.
排除标准
- •Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.
结局指标
主要结局
Primary Safety Endpoint is a composite of the following:
时间窗: The primary safety endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.
* Permanent disabling stroke (mRS \>2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)\* Note: If a subject dies prior to 1-year follow-up, their last recorded mRS will be considered their final score * Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension * All-cause mortality (within 1 year of either procedure) (\*Per VARC-3, disability assessment using the mRS should be performed between 30 and 90 days after a neurological event with 90 days being optimal. An increased mRS score by itself and in the absence of a neurological event does not constitute stroke.)
Primary Effectiveness Endpoint: Treatment Success
时间窗: The primary effectiveness endpoint will be measured at one-year after the index procedure and again at least 8 months after the (first) extension procedure.
Defined as device technical success (of either procedure) with absence of the following at 1-year: * Lesion-related mortality (defined as all deaths occurring within 30 days of, or, prior to discharge, from either the index procedure or the extension procedure or any revision procedures to treat the original lesion(s) and any other deaths adjudicated by Clinical Events Committee as related or probably related to the lesion(s)) * Aortic rupture in the treated segment * Lesion expansion (≥5mm increase from measurement at discharge/within 30 days) * Secondary intervention to address the following: * Stent graft-induced aortic wall injury (SAWI) * Fistula * Type I or III endoleak (see definitions) * Migration * Loss of Patency * Thromboembolic events * Failure of integrity
次要结局
- Secondary effectiveness endpoints will be reported(The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.)
- Secondary Safety Endpoints, Absence of the following(The secondary endpoints will be measured at each follow-up timepoint from discharge/30 days through to 10 years.)