ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- 30-day all-cause mortality
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
30-day all-cause mortality
Time Frame: 30 days
30-day all-cause mortality
Secondary Outcomes
- 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)
Investigators
Weiwei Wu
Chief Physician, Professor
Beijing Tsinghua Chang Gung Hospital