Dissection of the Superior Mesenteric Artery

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.

Study Overview

• Status: Completed
• Conditions: Dissection of the Superior Mesenteric Artery
• Intervention / Treatment: Behavioral: Observe the prognosis after stent implantation

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

SIDSMA patients receiving stent therapy

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

1. Those suffering from mental illness or subjectively unable to cooperate;
2. Patients with asymptomatic spontaneous solitary superior mesenteric artery dissection or only superior mesenteric artery intermural hematoma;
3. Patients with signs of peritonitis (tenderness, rebound pain, flat abdomen) and suggest severe intestinal ischemia;
4. Patients with strangulated intestinal obstruction;
5. Other patients who plan to undergo open surgery;
6. Women who are breastfeeding or pregnant, or women or men who have recent birth plans;
7. Life expectancy <2 years;
8. Patients who are currently participating in other interventional drug or device research, or have been enrolled in this research;
9. 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);
10. Diagnose active systemic infection or uncontrolled coagulation dysfunction within 14 days before operation;
11. History of previous superior mesenteric artery surgery;
12. 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
13. 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.)
14. 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
15. Does not meet the expected intraoperative and postoperative treatment plan
16. The diameter of the true lumen in the anchoring area of the SMA distal stent is less than 3mm

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-related mortality at 1, 6, and 12 months after surgery	Disease-related mortality at 1, 6, and 12 months after surgery	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	1/6/12months
Dissection shape at 1, 6, and 12 months after surgery	Dissection shape at 1, 6, and 12 months after surgery	1/6/12months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: First People's Hospital of Hangzhou; The First Affiliated Hospital of Anhui Medical University; First Affiliated Hospital Xi'an Jiaotong University; Shandong Provincial Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; First Affiliated Hospital of Chongqing Medical University; People's Hospital of Dangyang; Affiliated Hospital of Jiaxing University; Nanfang Hospital, Southern Medical University
• Investigators: Study Chair: Hongkun zhang, First Affiliated Hospital of Zhejiang University

Publications and helpful links

General 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.
• Wang 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.
• Qiu 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IIT20210045B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No