ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery

NCT07741318 | Active Not Recruiting DMC

• 1 other identifier: 26908-4-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Mesenteric Ischemia

Keywords

acute mesenteric ischemia

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause mortality

  30-day all-cause mortality

  30 days

Secondary Outcomes (14)

• 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

Study Arms (1)

thrombus aspiration-based endovascular and laparoscopic exploration

EXPERIMENTAL

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.

Procedure: thrombus aspiration-based endovascular therapy

Interventions

thrombus aspiration-based endovascular therapy PROCEDURE

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.

thrombus aspiration-based endovascular and laparoscopic exploration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• West China Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Tianjin Nankai Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Loudi Central Hospital: collaborator

Study Sites (1)

Intestinal Stroke Center of Beijing Tsinghua Changgung Hospital

Beijing, 102200, China

Location

Related Publications (1)

• Guo S, Zhao K, Zhu R, Cao Z, Zhang P, Li Y, Wu W. Selective minimally invasive strategy for acute superior mesenteric artery obstruction. J Vasc Surg. 2025 May;81(5):1083-1091.e1. doi: 10.1016/j.jvs.2025.01.033. Epub 2025 Jan 21.

  PMID: 39848506 BACKGROUND

Study Officials

• Weiwei Wu, Chief Physician

  Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Model Details: prospective, multicenter, single-arm clinical trial.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 3, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)