Evaluating outcomes for patients with dissection of the superior mesenteric artery treated with stents

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

This study is testing how well stents work for people with a specific type of artery problem in their stomach to see how they recover and what their long-term health looks like after treatment.

Quick facts

• Study type: Observational
• Enrollment: 136 (estimated)
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05171842 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with spontaneous solitary dissection of the superior mesenteric artery (SIDSMA) who have undergone stent implantation. The study aims to assess the prognosis of these patients following their treatment, which includes the use of stents to restore blood flow and potential additional interventions like embolization. Patients will be monitored post-surgery to evaluate their recovery and long-term outcomes. The study requires informed consent and involves follow-up observations over time.

Who should consider this trial

Good fit: Ideal candidates are patients with symptomatic spontaneous solitary dissection of the superior mesenteric artery diagnosed within one month of onset.

Not a fit: Patients with asymptomatic dissection or those requiring immediate surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of stent treatment for patients with superior mesenteric artery dissection, potentially improving patient management and outcomes.

How similar studies have performed: While there have been studies on stent use in vascular conditions, this specific approach to SIDSMA is less commonly explored, making it a novel investigation.

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

Where this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Hongkun zhang

Conditions: Dissection of the Superior Mesenteric Artery