Acute Mesenteric IschemiaBOWEL-2NCT07741318
ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery
A study testing thrombus aspiration-based endovascular therapy in people with Acute Mesenteric Ischemia, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Mesenteric Ischemia
- What is being tested?
- thrombus aspiration-based endovascular therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Intestinal Stroke Center of Beijing Tsinghua Changgung Hospital
Beijing, 102200
About this study
Official title: ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study
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
- Being tested
- thrombus aspiration-based endovascular therapy
- Keywords
- acute mesenteric ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombus aspiration-based endovascular therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: thrombus aspiration-based endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
30-day all-cause mortality
Measured: 30 days
Secondary outcomes (14)
Mortality rate
Cumulative mortality.
Measured: 1 year
Residual stenosis rate
Residual stenosis rate following thrombus aspiration with or without adjunctive endovascular therapy.
Measured: Immediately after the operation
Technical success rate
Technical success rate of thrombus aspiration with or without adjunctive endovascular therapy.
Measured: Immediately after the operation
Primary patency
Maintenance of vessel patency without the need for additional revascularization procedures
Measured: 1 year
Assisted primary patency
maintenance of vessel patency following prophylactic reintervention to prevent stent occlusion or progression of restenosis
Measured: 1 year
Incidence of bowel resection.
Incidence of bowel resection
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 year
Length of hospital stay
Length of hospital stay
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy
Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start10 Jul 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multicenter, single-arm clinical trial.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Weiwei Wu, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Weiwei Wu, Chief Physician, Study chair, Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741318
- Sponsor's protocol ID
- 26908-4-01
- Acronym
- BOWEL-2
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39848506
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery: a Multicenter, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07741318
- Acronym / sponsor ID
- BOWEL-2 / 26908-4-01
- Conditions
- Acute Mesenteric Ischemia
- Keywords
- acute mesenteric ischemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- 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 start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multicenter, single-arm clinical trial.
| Arm | Type | Receives |
|---|---|---|
| thrombus aspiration-based endovascular and laparoscopic exploration | Experimental | Procedure: thrombus aspiration-based endovascular therapyEligible 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombus aspiration-based endovascular therapyEligible 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 or surgery | thrombus aspiration-based endovascular and laparoscopic exploration |
Primary outcome
30-day all-cause mortality
Time frame: 30 days
30-day all-cause mortality
14 secondary outcomes
Mortality rate
Time frame: 1 year
Residual stenosis rate
Time frame: Immediately after the operation
Technical success rate
Time frame: Immediately after the operation
Primary patency
Time frame: 1 year
Assisted primary patency
Time frame: 1 year
Incidence of bowel resection.
Time frame: 1 year
Chronic intestinal failure (CIF)-free survival
Time frame: 1 year
Incidence of systemic inflammatory response syndrome (SIRS)
Time frame: In-hospital (up to 1 month)
Subgroup analyses
Time frame: 1 year
Length of hospital stay
Time frame: In-hospital (up to 1 month)
Treatment escalation
Time frame: In-hospital (up to 1 month)
Major bleeding
Time frame: 30 days
Device- or procedure-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: 1 year
Other AEs and SAEs related to anticoagulation and/or thrombolytic therapy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 39848506Guo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwei Wu, Chief Physician study chair
Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombus aspiration-based endovascular therapy in people with Acute Mesenteric Ischemia, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07741318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.