Multi-center, Randomized, Controlled Clinical Trial of BioGlue Surgical Adhesive as an Adjunct for Structural Repair and Hemostasis in Chinese Patients With Acute Type A Aortic Dissections.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 7
- 主要终点
- Successful Closure of the False Lumen
研究概览
简要总结
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.
详细描述
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis in Chinese subjects with acute type A aortic dissection. The trial consists of three phases:
Phase One - A non-randomized, lead-in phase. During the lead-in phase, the first 2-3 eligible subjects at each center will receive BioGlue in open surgery. These subjects will be evaluated for safety separately from the randomized phase of the trial.
Phase Two - A randomized, controlled phase. Type A aortic dissection subjects will be randomized into TSR group (control group) and surgical repair with BioGlue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured.
Phase Three - A Follow-up of Late Safety Outcomes of using BioGlue in "The CHINA Trial" . Subjects enrolled in "The CHINA Trial," from both the BioGlue and the control (TSR) group, will be invited to participate. Clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.
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
- •Male or female subjects 18-70 years of age.
- •Subject has a confirmed diagnosis of acute type A aortic dissection with subtype A
- •Subject is willing and able to give written consent for the trial. If the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation.
排除标准
- •Subjects with known allergy to albumin, bovine products, or glutaraldehyde.
- •Subjects who have been treated with an investigational product who have not completed the entire follow-up period.
- •Subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator.
- •Subjects with previous cardiac and aortic surgery.
- •End stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure).
- •Subjects with Marfan syndrome or other connective tissue disorders.
- •Previous chronic dissections resulting from non-cardiac surgery and/or trauma.
- •Concomitant surgery of valve replacement (both in screening and intraoperative).
结局指标
主要结局
Successful Closure of the False Lumen
时间窗: This success can be visually confirmed intraoperatively with a TEE (binary yes/no expression for each subject)
Successful closure of the false lumen as determined by intraoperative TEE. With successful closure of the false lumen, a complete disappearance of the false lumen will be achieved.
次要结局
- Treatment failure of the aortic dissection repair site identified in "The CHINA Trial" which leads to either post-discharge mortality or re-operation.(The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op))
- Proportion of subjects with device-related or procedure-related adverse events, determined by the investigators.(The measurement begins at discharge and will end when the retrospective chart review is performed by the hospital (could be up to 3 years post-op).)
- Successful closure of the false lumen by CTA or TTE at discharge(CTA or TTE scan at discharge or at 20 days (+/- 10 days) post-operatively for subjects with longer hospital stays.)
- Evaluate the successful hemostasis at the anastomotic site(The measurement begins intraoperatively after either BioGlue or Traditional Surgical Repair is applied to the anastomotic suture line(s) and the bypass cross clamp is released.)
- Time to repair the sinuses of Valsalva(The time for repairing the sinuses of Valsalva will be documented intraoperatively.)