Safety and Efficacy of Endovascular Treatment in Patients With Spontaneous Isolated Superior Mesenteric Artery Dissection: a Multicenter, Prospective Single-arm Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Re-intervention rate at 12 months after endovascular treatment
研究概览
简要总结
This study aims to evaluate the prognosis of patients with spontaneous solitary dissection of superior mesenteric artery (SIDSMA) who have been treated with stents.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
- •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
结局指标
主要结局
Re-intervention rate at 12 months after endovascular treatment
时间窗: 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
次要结局
- 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(1/6/12months)
- Dissection shape at 1, 6, and 12 months after surgery(1/6/12months)