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

NCT05342233 | Recruiting

• 1 other identifier: ISMAD2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Isolated Superior Mesenteric Artery Dissection

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality during follow-up period

  up to 5 years

• Rate of symptom relief

  Rate of symptom relief during follow-up period

  up to 5 years

Secondary Outcomes (4)

• Reintervention rate

  Follow-up period（ 5 years）

• Recurrence rate

  Follow-up period（5 years）

• Disease-related complications

  Follow-up period（5 years）

• Complete remodeling rate of superior mesenteric artery dissection

  Follow-up period（5 years）

Study Arms (2)

Endovascular treatment Group

Patients receiving endovascular treatments

Conservative treatment Group

Patients receiving conservative treatments, including blood pressure control, bowel rest, antithrombotic therapy, nutrition treatment and pain management.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• The First Medical Center of Chinese PLA General Hospital: collaborator
• West China Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Peking University Shenzhen Hospital: collaborator
• Affiliated Hospital of Chengde Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Henan Provincial People's Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Central Study Contacts

Wang WEI, Ph.D.

CONTACT

13808482650; weiwangcsu@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 22, 2022
• Study Start: April 30, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CN (1)