Acute Mesenteric Ischemia
Conditions
Keywords
acute mesenteric ischemia
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.
Interventions
PROCEDUREthrombus aspiration-based endovascular therapy
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.
Sponsors
Beijing Tsinghua Chang Gung Hospital
West China Hospital
The First Affiliated Hospital of Anhui Medical University
Tianjin Nankai Hospital
The Second Affiliated Hospital of Harbin Medical University
Loudi Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, multicenter, single-arm clinical trial.
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day all-cause mortality | 30 days | 30-day all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 1 year | Cumulative mortality. |
| Residual stenosis rate | Immediately after the operation | Residual stenosis rate following thrombus aspiration with or without adjunctive endovascular therapy. |
| Technical success rate | Immediately after the operation | Technical success rate of thrombus aspiration with or without adjunctive endovascular therapy. |
| Primary patency | 1 year | Maintenance of vessel patency without the need for additional revascularization procedures |
| Assisted primary patency | 1 year | maintenance of vessel patency following prophylactic reintervention to prevent stent occlusion or progression of restenosis |
| Incidence of bowel resection. | 1 year | Incidence of bowel resection |
| Chronic intestinal failure (CIF)-free survival | 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. |
| Incidence of systemic inflammatory response syndrome (SIRS) | 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). |
| Subgroup analyses | 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. |
| Length of hospital stay | In-hospital (up to 1 month) | Length of hospital stay |
| Treatment escalation | In-hospital (up to 1 month) | Treatment escalation, defined as the need for additional or more invasive therapeutic interventions after the index procedure. |
| Major bleeding | 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. |
| Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs) | 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. |
| Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy | 1 year | Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy. |
Countries
China
Contacts
STUDY_CHAIRWeiwei Wu, Chief Physician
Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
Outcome results
None listed