A Prospective, Randomized, Non-Inferiority Trial of AAR/AAR+HAR Versus AAR+TAR+FET in Type A Aortic Intramural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Rate of reintervention on the aortic arch or descending aorta
研究概览
简要总结
This is a prospective, randomized, non-inferiority clinical trial designed to compare the efficacy and safety of two surgical strategies for acute type A aortic intramural hematoma (TAIMH): (1) ascending aorta replacement or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), and (2) ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). Patients will be enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Eligible participants will be randomized in a 1:1 ratio to either group. The primary endpoint is the rate of reintervention on the aortic arch or descending aorta from 6 to 12 months after surgery. Secondary endpoints include circulatory arrest time, aortic cross-clamp time, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. A total of 400 participants will be enrolled.
详细描述
This is a prospective, randomized, controlled, non-inferiority study comparing two surgical strategies for acute type A aortic intramural hematoma (TAIMH). Patients with acute TAIMH will be screened and enrolled based on CTA confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Participants will be randomly assigned in a 1:1 ratio to receive either AAR/AAR+HAR or AAR+TAR+FET, with 200 participants in each group. Postoperative CTA will be performed before discharge, and follow-up CTA will be performed at 6 to 12 months after surgery.
The surgical procedure will be performed through a median sternotomy or upper partial sternotomy. Cardiopulmonary bypass will be established through right axillary/femoral arterial and bicaval venous cannulation, or femoral arteriovenous cannulation and superior vena cava cannulation. Left ventricular venting will be achieved via the right superior pulmonary vein. Antegrade HTK or cold blood cardioplegia will be administered under direct vision and repeated every 30 minutes. During circulatory arrest, bilateral selective antegrade cerebral perfusion will be provided via the right axillary artery and left common carotid artery.
The primary endpoint is the rate of reintervention on the aortic arch or descending aorta from 6 to 12 months after surgery. Secondary endpoints include circulatory arrest time, aortic cross-clamp time, major adverse cardiovascular events, other perioperative complications, and total hospitalization cost. The trial is designed to test whether the less extensive AAR/AAR+HAR strategy is non-inferior to AAR+TAR+FET with respect to the primary endpoint, while potentially offering advantages in operative burden, perioperative safety, and hospitalization cost.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant Blinding: The patient will not be informed of whether they received a Ascending Aorta/Hemiarch or Total Arch Replacement procedure. This is maintained through consistent post-operative communication that does not disclose the specific surgical technique.
Outcome Assessor Blinding: Members of the independent clinical event adjudication/imaging review team who assess reintervention-related outcomes are blinded to treatment allocation.
Care Provider (Surgeon) Blinding: The operating surgeons cannot be blinded due to the nature of the surgical interventions.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 80 years.
- •Diagnosis of type A aortic intramural hematoma (TAIMH).
- •Ability to understand the study procedure and provide written informed consent.
排除标准
- •Preoperative CTA shows an open or partially thrombosed (mixed) false lumen in the ascending aorta or arch.
- •Primary tear located on the greater curvature of the aortic arch, necessitating total arch replacement.
- •Planned concomitant major cardiac surgery (e.g., CABG, valve replacement, atrial fibrillation ablation).
- •Previous history of aortic arch or distal aortic surgery.
- •Severe peripheral vascular disease or cerebrovascular anatomy abnormality.
- •Active systemic infection, malignancy, severe hepatic or renal dysfunction, or other major comorbidities with life expectancy < 1 year or deemed unfit for complex cardiovascular surgery.
- •Pregnancy or lactation.
- •Severe psychiatric or cognitive disorders affecting compliance or follow-up.
研究组 & 干预措施
AAR/AAR+HAR Group
Participants randomized to this group will undergo ascending aorta replacement alone or ascending aorta plus hemiarch replacement (AAR/AAR+HAR), according to the operative strategy. This procedure involves replacing the ascending aorta with or without replacement of the proximal aortic arch while preserving the distal arch and supra-aortic vessels.
干预措施: Ascending Aorta Replacement / Ascending Aorta Plus Hemiarch Replacement (Procedure)
AAR+TAR+FET Group
Participants randomized to this group will undergo ascending aorta replacement with total arch replacement and frozen elephant trunk implantation (AAR+TAR+FET). This procedure involves replacement of the entire aortic arch combined with frozen elephant trunk repair of the proximal descending aorta.
干预措施: Ascending Aorta Replacement With Total Arch Replacement and Frozen Elephant Trunk (Procedure)
结局指标
主要结局
Rate of reintervention on the aortic arch or descending aorta
时间窗: 6 to 12 months after surgery
The proportion of patients requiring any secondary surgical or endovascular procedure involving the aortic arch or descending aorta during follow-up after the index operation.
Rate of Perioperative False Lumen Patency in the Aortic Arch and Descending Aorta
时间窗: At hospital discharge, an average of 5 to 14 days post-operatively
This outcome measures the proportion of patients with patency (re-canalization) of the false lumen in both the aortic arch and descending aorta during the immediate postoperative period before hospital discharge.
次要结局
- Aortic Cross-Clamp Time(Intraoperative)
- Circulatory Arrest Time(Intraoperative)
- Operation Time(Intraoperative)
- Major Adverse Cardiovascular Events (MACE)(Through 30 days after surgery)
- Other perioperative complications(Through 30 days after surgery)
- Total hospitalization cost(Through hospital discharge)
- Aortic Cross-Clamp Time(Intraoperative period.)
- Total Operation Time(Intraoperative period.)
- Perioperative Complications(30 days after surgery)
- rate of false lumen patency in the aortic arch and descending aorta at 6 - 12 months(One assessment performed between 6 and 12 months post-operatively.)
- Circulatory Arrest Time(Intraoperative period.)
- Rate of Re-intervention on the Aorta(6 months post-operatively)
研究者
Kexiang Liu, MD
Department of Cardiovascular Surgery, Second Hospital of Jilin University
Second Hospital of Jilin University