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Dissection of the Superior Mesenteric Artery

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Zhejiang University

Status

Completed

Conditions

Dissection of the Superior Mesenteric Artery

Treatments

Behavioral: Observe the prognosis after stent implantation

Study type

Observational

Funder types

Other

Identifiers

NCT05171842
IIT20210045B

Details and patient eligibility

About

This study aims to evaluate the prognosis of patients with spontaneous solitary dissection of superior mesenteric artery (SIDSMA) who have been treated with stents.

Full 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.

Enrollment

136 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Hongkun zhang

Data sourced from clinicaltrials.gov

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