B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 590
- 试验地点
- 2
- 主要终点
- All-cause mortality
研究概览
简要总结
A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.
详细描述
The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study.
- •Expected life expectancy of greater than two years after repair
- •Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair
排除标准
- •Subject is unfit for open surgical repair involving circulatory arrest
- •Subject is comatose or suffering from irreversible severe brain malperfusion
- •Subject has known sensitivity to components of the devices
- •Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
- •Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study
- •Subject has an uncorrectable bleeding anomaly
- •Subject has any other 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
- •Subject is pregnant
结局指标
主要结局
All-cause mortality
时间窗: Up to 30 days
Individual rate of occurrence of the death from all-cause
Stroke, excluding TIA
时间窗: Up to 30 days
Individual rate of occurrence of stroke
Technical success
时间窗: 24 hours
Composite of the following criteria: successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival
Patency of all graft/endograft components
时间窗: At hospital discharge or at 1 month
Patent graft/endografts confirmed by CT imaging assessment
Complete sealing of the aortic pathology
时间窗: At hospital discharge or 1 month
Absence of Type Ia and IIIa/b endoleak, complete coverage of PAU cases, and isolation of the primary entry tear in dissection cases confirmed by CT imaging assessment
Paralysis, excluding paraparesis
时间窗: Up to 30 days
Individual rate of occurrence of paralysis
次要结局
- Device migration(Up to 36 months after the index procedure)
- Incidence of Type III endoleak related to the extension device(Up to 36 months after the index procedure)
- Thromboembolic events(Up to 36 months after the index procedure)
- Incidence of all endoleak types(Up to 36 months after the index procedure)
- Migration of the distal extension(Up to 36 months after the index procedure)
- Non-serious and serious adverse events(Up to 36 months after the index procedure)
- Failure of device-extension integrity resulting in a compromised seal and blood leakage or movement of the device(Up to 36 months after the index procedure)
- Incidence of failed patency of the device-extension overlap(Up to 36 months after the index procedure)
- Incidence of MAE at 30 days post-extension(Up to 36 months after the index procedure)
- Incidence of secondary procedures related to the extension(Up to 36 months after the index procedure)
- Aortic related death(Up to 36 months after the index procedure)
- Renal failure requiring dialysis(Up to 36 months after the index procedure)
- Pseudoaneurysm at the treatment sites(Up to 36 months after the index procedure)
- Late Type III endoleak(Up to 36 months after the index procedure)
- Device crimping/kinking(Up to 36 months after the index procedure)
- Non-cardiac/non-aortic re-operations(Up to 36 months after the index procedure)
- Aortic rupture(Up to 36 months after the index procedure)
- Device integrity failures(Up to 36 months after the index procedure)
- Late Type I endoleak(Up to 36 months after the index procedure)
- Vocal Cord paralysis(Up to 36 months after the index procedure)
- Myocardial infarction(Up to 36 months after the index procedure)
- Respiratory failure(Up to 36 months after the index procedure)
- Failed patencies in graft, or endovascular stent-graft including the branch(es)(Up to 36 months after the index procedure)
- Secondary unplanned interventions in the treated vascular segment or related to the original pathology(Up to 36 months after the index procedure)
- Thrombosis of the device lumen(Up to 36 months after the index procedure)
- Surgical graft/stentgraft infection(Up to 36 months after the index procedure)
- Unanticipated aortic or branch-related re-operation(Up to 36 months after the index procedure)
研究者
Eric Roselli, M. D.
Sponsor/Principal Investigator
The Cleveland Clinic