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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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.
Intestinal Stroke Center of Beijing Tsinghua Changgung Hospital
Beijing, China
30-day all-cause mortality
30-day all-cause mortality
Time frame: 30 days
Mortality rate
Cumulative mortality.
Time frame: 1 year
Residual stenosis rate
Residual stenosis rate following thrombus aspiration with or without adjunctive endovascular therapy.
Time frame: Immediately after the operation
Technical success rate
Technical success rate of thrombus aspiration with or without adjunctive endovascular therapy.
Time frame: Immediately after the operation
Primary patency
Maintenance of vessel patency without the need for additional revascularization procedures
Time frame: 1 year
Assisted primary patency
maintenance of vessel patency following prophylactic reintervention to prevent stent occlusion or progression of restenosis
Time frame: 1 year
Incidence of bowel resection.
Incidence of bowel resection
Time frame: 1 year
Chronic intestinal failure (CIF)-free survival
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.
Time frame: 1 year
Incidence of systemic inflammatory response syndrome (SIRS)
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).
Time frame: In-hospital (up to 1 month)
Subgroup analyses
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.
Time frame: 1 year
Length of hospital stay
Length of hospital stay
Time frame: In-hospital (up to 1 month)
Treatment escalation
Treatment escalation, defined as the need for additional or more invasive therapeutic interventions after the index procedure.
Time frame: In-hospital (up to 1 month)
Major bleeding
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.
Time frame: 30 days
Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs)
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.
Time frame: 1 year
Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy
Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy.
Time frame: 1 year
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