Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Number of patients experiencing a composite end-point of mortality or re-intervention
研究概览
简要总结
HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.
详细描述
DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.
HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hemiarch repair
Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.
干预措施: Hemiarch repair (Procedure)
Extended arch repair
Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.
干预措施: Extended arch repair (Procedure)
结局指标
主要结局
Number of patients experiencing a composite end-point of mortality or re-intervention
时间窗: 3 years
Compare the proportion of patients between the two groups who over a 3 year follow up period attain a composite clinical end-point of 1) mortality, 2) late aortic re-intervention, either surgical or endovascular (\> 30 days from index procedure) or 3) early (\< 30 days from index procedure) re-intervention for branch malperfusion
次要结局
- Delta change in maximum cross-sectional descending thoracic aortic dimension(3 years)
- Preoperative malperfusion and perioperative mortality/early re-intervention(1 month)
- Number of patients experiencing the listed peri-operative complications(1 month)
- Delta change in the ratio of true lumen to total aortic area (TL: Ao)(1 month)
- Number of patients achieving complete false lumen thrombosis on CT imaging(3 years)
- Number of patients requiring open surgical or endovascular re-intervention(3 years)