ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 30-day all-cause mortality
研究概览
简要总结
This study is designed as a prospective, multicenter, single-arm clinical trial. Patients with acute mesenteric ischemia (AMI) caused by superior mesenteric artery (SMA) thrombosis or thromboembolism will be enrolled. Eligible participants will undergo treatment using a peripheral thrombus aspiration catheter to evaluate the safety and efficacy of thrombus aspiration-based endovascular therapy for acute mesenteric ischemia.
According to the BOWEL2 stratified diagnostic and treatment algorithm, laparoscopic exploration will be performed when indicated. In cases where intestinal necrosis is suspected, conversion to open laparotomy will be conducted, followed by resection of the necrotic bowel segment.
This study will be conducted across multiple clinical research centers in China. A total of 76 participants are planned to be enrolled. All participants will undergo follow-up assessments during the procedure, before hospital discharge, and at 30 days, 3 months, 6 months, and 12 months after the procedure.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, with no restriction on sex.
- •Acute mesenteric ischemia (AMI) caused by superior mesenteric artery (SMA) thrombosis or thromboembolism.
- •The participant or legally authorized representative can provide written informed consent, and the participant is willing and able to comply with the follow-up requirements.
排除标准
- •Presence of unfavorable vascular anatomical factors, including severe arterial tortuosity, concomitant aortic disease, superior mesenteric artery aneurysm, or other anatomical conditions considered unsuitable for endovascular intervention.
- •Acute major myocardial infarction, extensive cerebral infarction, or severe heart failure within 1 month before enrollment.
- •Patients unable to receive regular anticoagulation, thrombolytic therapy, or antiplatelet therapy due to gastrointestinal bleeding, severe allergic reactions, coagulation disorders, severe hepatic or renal dysfunction, or other contraindications.
- •Patients unable to undergo endovascular procedures due to severe contrast media allergy, severe renal insufficiency, or other contraindications.
- •History of previous superior mesenteric artery (SMA) thromboembolism or thrombosis.
- •Patients with confirmed intestinal necrosis before the procedure who underwent direct exploratory laparotomy without receiving endovascular intervention.
- •Pregnant or breastfeeding women.
- •Patients currently participating in other interventional device or drug clinical trials.
- •Any other conditions deemed inappropriate for enrollment by the investigator.
结局指标
主要结局
30-day all-cause mortality
时间窗: 30 days
30-day all-cause mortality
次要结局
- Mortality rate(1 year)
- Residual stenosis rate(Immediately after the operation)
- Technical success rate(Immediately after the operation)
- Primary patency(1 year)
- Assisted primary patency(1 year)
- Incidence of bowel resection.(1 year)
- Chronic intestinal failure (CIF)-free survival(1 year)
- Incidence of systemic inflammatory response syndrome (SIRS)(In-hospital (up to 1 month))
- Subgroup analyses(1 year)
- Length of hospital stay(In-hospital (up to 1 month))
- Treatment escalation(In-hospital (up to 1 month))
- Major bleeding(30 days)
- Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs)(1 year)
- Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy(1 year)
研究者
Weiwei Wu
Chief Physician, Professor
Beijing Tsinghua Chang Gung Hospital