Xiangya Hospital of Central South University
Changsha, Hunan, China
Location status: Recruiting
Recruiting
NCT Number: NCT05342233
Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Aged 18 and above;
- Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
- Signed informed consent forms, willing to receive treatments
Exclusion criteria
- Symptoms are severe and patients need exploratory laparotomy;
- Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
- Patients with mental illness cannot cooperate subjectively;
- Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
- Pregnancy and breastfeeding women, or patients who have recent birth plans;
- Patients who are participating in other clinical projects;
- Patients are not suitable to participate in this study.
Treatment and study plan
Primary outcomes
-
Mortality
Time frame: up to 5 years
Mortality during follow-up period
-
Rate of symptom relief
Time frame: up to 5 years
Rate of symptom relief during follow-up period
Secondary outcomes
-
Reintervention rate
Time frame: Follow-up period（ 5 years）
Reintervention related to SISMAD after treatments during follow-up period
-
Recurrence rate
Time frame: Follow-up period（5 years）
SISMAD Recurrence after treatments during follow-up period
-
Disease-related complications
Time frame: Follow-up period（5 years）
Disease-related complications after treatments during follow-up period
-
Complete remodeling rate of superior mesenteric artery dissection
Time frame: Follow-up period（5 years）
Complete remodeling rate of superior mesenteric artery dissection after receiving different treatments
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Xiangya Hospital of Central South University
Other
Collaborators
- Affiliated Hospital of Chengde Medical University
- Henan Provincial People's Hospital
- Peking University Shenzhen Hospital
- Renmin Hospital of Wuhan University
- Second Affiliated Hospital of Nanchang University
- The Affiliated Hospital of Inner Mongolia Medical University
- The First Medical Center of Chinese PLA General Hospital
- West China Hospital
Registry information
Official study title
Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection: A Real-world, Multicenter, Observational Study
Important dates
- Study start
- 2022
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Apr 22, 2022
- Registry last updated
- Apr 22, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.