Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection

Recruiting

• Conditions: Spontaneous Isolated Superior Mesenteric Artery Dissection

• Registration Number: NCT05342233
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Study Start: 2022-04-30
• Primary Completion: 2027-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged 18 and above;
2. Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
3. Signed informed consent forms, willing to receive treatments

Exclusion Criteria

1. Symptoms are severe and patients need exploratory laparotomy;
2. Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
3. Patients with mental illness cannot cooperate subjectively;
4. Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
5. Pregnancy and breastfeeding women, or patients who have recent birth plans;
6. Patients who are participating in other clinical projects;
7. Patients are not suitable to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	up to 5 years	Mortality during follow-up period
Rate of symptom relief	up to 5 years	Rate of symptom relief during follow-up period

Secondary Outcome Measures

Name	Time	Method
Reintervention rate	Follow-up period（ 5 years）	Reintervention related to SISMAD after treatments during follow-up period
Recurrence rate	Follow-up period（5 years）	SISMAD Recurrence after treatments during follow-up period
Complete remodeling rate of superior mesenteric artery dissection	Follow-up period（5 years）	Complete remodeling rate of superior mesenteric artery dissection after receiving different treatments
Disease-related complications	Follow-up period（5 years）	Disease-related complications after treatments during follow-up period

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China