NCT04246463招募中不适用
A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Vascutek Ltd.58 个研究点 分布在 8 个国家目标入组 1,000 人开始时间: 2019年12月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 58
- 主要终点
- Aortic Related Mortality
研究概览
简要总结
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
详细描述
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical 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
- •Minimum age as per local regulations
- •Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
- •Ability to provide informed consent
- •o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR).
- •Willingness to comply with the registry protocol
- •Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.
排除标准
- •Patient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.
研究组 & 干预措施
Thoracic - TEVAR
干预措施: Thoracic (Device)
Abdominal - EVAR
干预措施: Abdominal (Device)
Custom Device
干预措施: Custom Device (Device)
Other indications
Isolated Iliac Artery Aneurysm (IIAA)
干预措施: Illiac Artery (Device)
结局指标
主要结局
Aortic Related Mortality
时间窗: 30 days post implant
Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion
次要结局
- Technical Success(Day 0)
- Composite Clinical Success(1 year)
- Additional Endpoints(1 year)
研究者
研究点 (58)
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