Dissection of the Superior Mesenteric ArteryNCT05171842
Dissection of the Superior Mesenteric Artery
An observational study of Dissection of the Superior Mesenteric Artery, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study aims to evaluate the prognosis of patients with spontaneous solitary dissection of superior mesenteric artery (SIDSMA) who have been treated with stents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dissection of the Superior Mesenteric Artery
- What is being tested?
- Observe the prognosis after stent implantation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2021to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: SIDSMA patients receiving stent therapy
Who may be able to join
- Superior mesenteric artery dissection with obvious abdominal symptoms within 1 month of onset
- CTA/DSA diagnosed as spontaneous superior mesenteric artery dissection; ③ CTA/DSA diagnosed as a solitary superior mesenteric artery dissection; ④ Sign the informed consent form and be willing to accept follow-up observation;
Who cannot join
- Those suffering from mental illness or subjectively unable to cooperate;
- Patients with asymptomatic spontaneous solitary superior mesenteric artery dissection or only superior mesenteric artery intermural hematoma;
- Patients with signs of peritonitis (tenderness, rebound pain, flat abdomen) and suggest severe intestinal ischemia;
- Patients with strangulated intestinal obstruction;
- Other patients who plan to undergo open surgery;
- Women who are breastfeeding or pregnant, or women or men who have recent birth plans;
Show all 16Show fewer
- Life expectancy <2 years;
- Patients who are currently participating in other interventional drug or device research, or have been enrolled in this research;
- Patients with renal failure or chronic kidney disease have MDRD GFR ≤ 30ml/min/1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days before surgery, or receive dialysis treatment);
- Diagnose active systemic infection or uncontrolled coagulation dysfunction within 14 days before operation;
- History of previous superior mesenteric artery surgery;
- Failure to take medications as required by the protocol, or allergy to antiplatelet drugs (aspirin or clopidogrel), low molecular weight heparin, vasodilators or contrast agents, so that the preoperative and postoperative medication requirements cannot be fully complied with
- Combined with systemic diseases that cannot be controlled by the current medical level (such as severe heart function, lung function or liver function abnormalities, patients with advanced tumors, patients with cachexia, patients with severe coronary heart disease that cannot be relieved, abnormal blood coagulation caused by genetic diseases, etc.)
- Cerebral hemorrhage, symptomatic stroke, myocardial infarction, gastrointestinal hemorrhage in the past 6 months or the patient is under 18 years of age or the patient refuses to participate in the study
- Does not meet the expected intraoperative and postoperative treatment plan
- The diameter of the true lumen in the anchoring area of the SMA distal stent is less than 3mm
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Safety and Efficacy of Endovascular Treatment in Patients With Spontaneous Isolated Superior Mesenteric Artery Dissection: a Multicenter, Prospective Single-arm Observational Study
This study aims to evaluate the prognosis of patients with spontaneous solitary dissection of superior mesenteric artery (SIDSMA) who have been treated with stents.
Read the detailed description
This study is an observational study. The subject's treatment plan needs to be expected to meet the following conditions: the corresponding surgery has been completed: the femoral artery or brachial artery approach is implanted into the true lumen of the SMA bare stent (the part with a diameter ≤ 7mm is suggested to use thin-wall stent, and the part with a diameter> 7mm It is not limited to using stents (brands) to restore the real lumen blood flow of the superior mesenteric artery. If the false cavity is large, it can be combined with a spring coil to assist embolization. Anticoagulation therapy for at least 1 day after surgery. Anticoagulation drugs are not limited to use. After discharge, the dual-antiplatelet drugs for at least 3 months, and single antiplatelet should be maintained for at least 1 year.
- Being tested
- Observe the prognosis after stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe the prognosis after stent implantationBehavioural
Observe the prognosis of patients after undergoing specific operations. Specific surgery: Use femoral artery or brachial artery to implant bare stent (stent with diameter ≤7mm is suggested to use thin-wall stent, stents with >7mm are not restricted) to restore the blood flow of the true lumen superior mesenteric artery. If the false cavity is large, it can be combined with a spring coil to assist embolization. Anticoagulant therapy should be performed for at least 1 day after surgery. Anticoagulant drugs are not restricted. After discharge from the hospital, the dual anti-platelet drugs should be taken for 3 months, and a single anti-platelet drug should be maintained for at least 1 year.
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intervention rate at 12 months after endovascular treatment
Including surgery related to this disease (including surgical intervention at the puncture point) and symptom recurrence requires more than 3 days of conservative treatment
Measured: 12months
Secondary outcomes (3)
Disease-related mortality at 1, 6, and 12 months after surgery
Disease-related mortality at 1, 6, and 12 months after surgery
Measured: 1/6/12months
Stent patency rate at 1, 6, and 12 months after surgery
Stent patency rate at 1, 6, and 12 months after surgery
Measured: 1/6/12months
Dissection shape at 1, 6, and 12 months after surgery
Dissection shape at 1, 6, and 12 months after surgery
Measured: 1/6/12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start9 Sep 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dissection of the Superior Mesenteric ArteryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Chongqing Medical University, Shandong Provincial Hospital, Affiliated Hospital of Jiaxing University, People's Hospital of Dangyang, First People's Hospital of Hangzhou, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Hongkun zhang, Study chair, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171842
- Sponsor's protocol ID
- IIT20210045B
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qiu C, He Y, Li D, Shang T, Wang X, Wu Z, Zhang H. Mid-Term Results of Endovascular Treatment for Spontaneous Isolated Dissection of the Superior Mesenteric Artery. Eur J Vasc Endovasc Surg. 2019 Jul;58(1):88-95. doi: 10.1016/j.ejvs.2018.11.013. Epub 2019 May 31.
PubMed 31160187Wang B, Pan J, Xu Y, Qiu X, Ding Z, Li D, Zhang H, Qiu C, Wu Z. Long-term Outcomes of Endovascular Versus Medical Treatment for Isolated Superior Mesenteric Artery Dissection: A 10-Year Retrospective Study. Cardiovasc Intervent Radiol. 2025 May;48(5):593-602. doi: 10.1007/s00270-025-03985-0. Epub 2025 Feb 26.
PubMed 40011282Qiu C, Wu Z, He Y, Tian L, Zhu Q, Shang T, Zhang H, Li D. Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery. Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD014703. doi: 10.1002/14651858.CD014703.pub2.
PubMed 36074662
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endovascular Treatment in Patients With Spontaneous Isolated Superior Mesenteric Artery Dissection: a Multicenter, Prospective Single-arm Observational Study
- ClinicalTrials.gov ID
- NCT05171842
- Acronym / sponsor ID
- IIT20210045B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Chongqing Medical University, Shandong Provincial Hospital, Affiliated Hospital of Jiaxing University, People's Hospital of Dangyang, First People's Hospital of Hangzhou, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Dec 2021 (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 aims to evaluate the prognosis of patients with spontaneous solitary dissection of superior mesenteric artery (SIDSMA) who have been treated with stents.
Detailed description
This study is an observational study. The subject's treatment plan needs to be expected to meet the following conditions: the corresponding surgery has been completed: the femoral artery or brachial artery approach is implanted into the true lumen of the SMA bare stent (the part with a diameter ≤ 7mm is suggested to use thin-wall stent, and the part with a diameter> 7mm It is not limited to using stents (brands) to restore the real lumen blood flow of the superior mesenteric artery. If the false cavity is large, it can be combined with a spring coil to assist embolization. Anticoagulation therapy for at least 1 day after surgery. Anticoagulation drugs are not limited to use. After discharge, the dual-antiplatelet drugs for at least 3 months, and single antiplatelet should be maintained for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SIDSMA patients receiving stent therapy
Key inclusion criteria (2 listed)
- Superior mesenteric artery dissection with obvious abdominal symptoms within 1 month of onset
Key exclusion criteria (16 listed)
- Those suffering from mental illness or subjectively unable to cooperate;
- Patients with asymptomatic spontaneous solitary superior mesenteric artery dissection or only superior mesenteric artery intermural hematoma;
- Patients with signs of peritonitis (tenderness, rebound pain, flat abdomen) and suggest severe intestinal ischemia;
- Patients with strangulated intestinal obstruction;
- Other patients who plan to undergo open surgery;
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 |
|---|---|---|
| Observe the prognosis after stent implantationObserve the prognosis of patients after undergoing specific operations. Specific surgery: Use femoral artery or brachial artery to implant bare stent (stent with diameter ≤7mm is suggested to use thin-wall stent, stents with >7mm are not restricted) to restore the blood flow of the true lumen superior mesenteric artery. If the false cavity is large, it can be combined with a spring coil to assist embolization. Anticoagulant therapy should be performed for at least 1 day after surgery. Anticoagulant drugs are not restricted. After discharge from the hospital, the dual anti-platelet drugs should be taken for 3 months, and a single anti-platelet drug should be maintained for at least 1 year. | Behavioural | – |
Primary outcome
Re-intervention rate at 12 months after endovascular treatment
Time frame: 12months
Including surgery related to this disease (including surgical intervention at the puncture point) and symptom recurrence requires more than 3 days of conservative treatment
3 secondary outcomes
Disease-related mortality at 1, 6, and 12 months after surgery
Time frame: 1/6/12months
Stent patency rate at 1, 6, and 12 months after surgery
Time frame: 1/6/12months
Dissection shape at 1, 6, and 12 months after surgery
Time frame: 1/6/12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 31160187Qiu C, He Y, Li D, Shang T, Wang X, Wu Z, Zhang H. Mid-Term Results of Endovascular Treatment for Spontaneous Isolated Dissection of the Superior Mesenteric Artery. Eur J Vasc Endovasc Surg. 2019 Jul;58(1):88-95. doi: 10.1016/j.ejvs.2018.11.013. Epub 2019 May 31.
- Background: PubMed 40011282Wang B, Pan J, Xu Y, Qiu X, Ding Z, Li D, Zhang H, Qiu C, Wu Z. Long-term Outcomes of Endovascular Versus Medical Treatment for Isolated Superior Mesenteric Artery Dissection: A 10-Year Retrospective Study. Cardiovasc Intervent Radiol. 2025 May;48(5):593-602. doi: 10.1007/s00270-025-03985-0. Epub 2025 Feb 26.
- Background: PubMed 36074662Qiu C, Wu Z, He Y, Tian L, Zhu Q, Shang T, Zhang H, Li D. Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery. Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD014703. doi: 10.1002/14651858.CD014703.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Dissection of the Superior Mesenteric Artery
Active, not recruiting
The DISSECT Study: Effect of Peri-aDventItial SMA diSsECtion on Margin sTatus During Pancreaticoduodenectomy for Resectable Pancreatic Cancer
Pancreatic Adenocarcinoma
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.
Hongkun zhang study chair
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissection of the Superior Mesenteric Artery, run by First Affiliated Hospital of Zhejiang University 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 2 inclusion and 16 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: finished, as of the sponsor's last update on 4 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Re-intervention rate at 12 months after endovascular treatment (time frame: 12months). 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 NCT05171842, which also lists 3 linked publications.
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 4 Dec 2025.