ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery | NCT07741318

NCT07741318

Overview

NCT ID: NCT07741318
Lead Sponsor: Beijing Tsinghua Chang Gung HospitalOTHER
Official Title: ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study
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.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 10, 2026Actual
Primary Completion Date: Oct 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 76Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Intestinal Stroke Center of Beijing Tsinghua Changgung Hospital

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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