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Active, not recruiting

NCT Number: NCT07741318

ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Mesenteric Ischemia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intestinal Stroke Center of Beijing Tsinghua Changgung Hospital

Beijing, 102200, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 30-day all-cause mortality

    Time frame: 30 days

    30-day all-cause mortality

Secondary outcomes

  1. Mortality rate

    Time frame: 1 year

    Cumulative mortality.

  2. Residual stenosis rate

    Time frame: Immediately after the operation

    Residual stenosis rate following thrombus aspiration with or without adjunctive endovascular therapy.

  3. Technical success rate

    Time frame: Immediately after the operation

    Technical success rate of thrombus aspiration with or without adjunctive endovascular therapy.

  4. Primary patency

    Time frame: 1 year

    Maintenance of vessel patency without the need for additional revascularization procedures

  5. Assisted primary patency

    Time frame: 1 year

    maintenance of vessel patency following prophylactic reintervention to prevent stent occlusion or progression of restenosis

  6. Incidence of bowel resection.

    Time frame: 1 year

    Incidence of bowel resection

  7. Chronic intestinal failure (CIF)-free survival

    Time frame: 1 year

    Chronic intestinal failure (CIF) is defined as a persistent reduction in intestinal function below the minimum required for the absorption of macronutrients and/or water and electrolytes, necessitating intravenous supplementation (excluding disease-specific oral nutritional supplementation) to maintain health and/or growth.

  8. Incidence of systemic inflammatory response syndrome (SIRS)

    Time frame: In-hospital (up to 1 month)

    The presence of at least two of the following criteria: Body temperature <36°C or >38°C, Heart rate >90 beats/min, Tachypnea, Abnormal white blood cell count (WBC >12 × 10⁹/L, <4 × 10⁹/L, or >10% immature neutrophils).

  9. Subgroup analyses

    Time frame: 1 year

    eg. Embolic AMI (EAMI) versus thrombotic vascular AMI (VAMI); Balloon angioplasty versus no balloon angioplasty; Stent implantation versus no stent implantation; Thrombolysis versus no thrombolysis.

  10. Length of hospital stay

    Time frame: In-hospital (up to 1 month)

    Length of hospital stay

  11. Treatment escalation

    Time frame: In-hospital (up to 1 month)

    Treatment escalation, defined as the need for additional or more invasive therapeutic interventions after the index procedure.

  12. Major bleeding

    Time frame: 30 days

    Major bleeding is defined as Bleeding Academic Research Consortium (BARC) type 3b, 3c, 5a, 5b

    3b Overt bleeding with a hemoglobin drop of ≥5 g/dL (the hemoglobin decrease is related to the bleeding) Cardiac tamponade Bleeding requiring intravenous vasoactive agents Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid)

    3c Intracranial hemorrhage (excluding microbleeds or hemorrhagic transformation; including intraspinal hemorrhage). Subtype: confirmed by autopsy, imaging, or lumbar puncture Intraocular hemorrhage compromising vision

    5a: Probable fatal bleeding refers to bleeding that is clinically suspected as the cause of death but is not directly observed and is not confirmed by autopsy or imaging.

    5b: Definite fatal bleeding is defined as bleeding that is directly observed (from any clinical specimen [blood, vomitus, stool, etc.] or by imaging) or confirmed by autopsy.

  13. Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 1 year

    Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs) associated with thrombus aspiration and adjunctive endovascular therapy, including but not limited to distal embolization caused by thrombus fragmentation during aspiration resulting in occlusion of previously patent distal vessels.

  14. Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy

    Time frame: 1 year

    Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Collaborators

  • Loudi Central Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The Second Affiliated Hospital of Harbin Medical University
  • Tianjin Nankai Hospital
  • West China Hospital

Registry information

Official study title

ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study

Acronym: BOWEL-2

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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