Dissection of the Superior Mesenteric Artery

NCT ID: NCT05171842

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2025-02-28

Brief 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.

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.

Conditions

Dissection of the Superior Mesenteric Artery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observe the prognosis after stent implantation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

People's Hospital of Dangyang

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongkun zhang

Role: STUDY_CHAIR

First Affiliated Hospital of Zhejiang University

Locations

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 31160187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 40011282 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36074662 (View on PubMed)

Other Identifiers

IIT20210045B

Identifier Type: -

Identifier Source: org_study_id