Dissection of the Superior Mesenteric Artery

Dissection of the Superior Mesenteric Artery Clinical Trial

Official title:

Safety and Effectiveness of Endovascular Stent Therapy in Patients With Dissection of the Superior Mesenteric Artery: a Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171842
• Other study ID #: IIT20210045B
• Status: Recruiting
• Start date: September 9, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hongkun zhang
• Phone: 0571-87236745
• Email: 1198050[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Superior mesenteric artery dissection with obvious abdominal symptoms within 1 month of onset

• CTA/DSA diagnosed as spontaneous superior mesenteric artery dissection; ? CTA/DSA diagnosed as a solitary superior mesenteric artery dissection; ? 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

Related Conditions & MeSH terms

• Dissection of the Superior Mesenteric Artery

Intervention

Behavioral:
• 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 naked stent (stent with diameter =7mm, 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 double antibody should be taken for 3 months, and the monoclonal antibody should be maintained for at least 1 year.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (10)

Lead Sponsor

Collaborator

First Affiliated Hospital of Zhejiang University

Affiliated Hospital of Jiaxing University, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Nanfang Hospital, Southern Medical University, People's Hospital of Dangyang, Shandong Provincial Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Dissection shape at 1, 6, and 12 months after surgery	Dissection shape at 1, 6, and 12 months after surgery	1/6/12months