Clinical trial NCT05171842: Dissection of the Superior Mesenteric Artery
Official title: Safety and Effectiveness of Endovascular Stent Therapy in Patients With Dissection of the Superior Mesenteric Artery: a Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dissection of the Superior Mesenteric Artery
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: First Affiliated Hospital of Chongqing Medical University
name: Shandong Provincial Hospital
name: Affiliated Hospital of Jiaxing University
name: People's Hospital of Dangyang
name: First People's Hospital of Hangzhou
name: The First Affiliated Hospital of Anhui Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Nanfang Hospital, Southern Medical University
First posted: 2021-12-29
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SIDSMA patients receiving stent therapy

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 above the 100-strong 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, and discharge After taking the double antibody for 3 months, the monoclonal antibody should be maintained for at least 1 year.

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

Primary outcomes:
measure: Re-intervention rate at 12 months after endovascular treatment
timeFrame: 12months
Secondary outcomes:
measure: Disease-related mortality at 1, 6, and 12 months after surgery
timeFrame: 1/6/12months
measure: Stent patency rate at 1, 6, and 12 months after surgery
timeFrame: 1/6/12months
measure: Dissection shape at 1, 6, and 12 months after surgery
timeFrame: 1/6/12months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Hongkun zhang
role: STUDY_CHAIR
References:
citation: 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.