Stent Implantation for Patients With SIDSMA

Dissection of the Superior Mesenteric Artery Clinical Trial

Official title:

Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03916965
• Other study ID #: 2019.62
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the prognosis in patients with spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) who have been treated with stents.

Description:

This study is a prospective, observational study. Patients who have been diagnosed as spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) and treated with stents are enrolled in the study. We will evaluate the patency of stent, remodeling of the dissection and the relief of the symptoms in the next 1 years after patients have received stents.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female over 18 years of age

2. Diagnosed as spontaneous isolated dissection of the superior mesenteric artery

3. Patients have been successfully treated with stents

4. Patients are willing to participate in this study

Exclusion Criteria:

1. Life expectancy of < 5 years;

2. Other surgeries or endovascular treatments have been taken concurrently.

3. Elevated serum level

Related Conditions & MeSH terms

• Dissection of the Superior Mesenteric Artery

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of stents deployed in the superior mesenteric artery	The patency of stents deployed in the superior mesenteric artery shall be evaluated via computed tomographic angiography	12 months post-procedure
Primary	Remodeling of the superior mesenteric artery	Complete remodeling was defined as the absence of residual arterial dissection and stenosis via follow-up computed tomographic angiography. Incomplete remodeling was defined as improved luminal patency of the superior mesenteric artery but worse than complete remodeling.	12 months post-procedure
Secondary	Relief of symptoms	Most of patients with SIDSMA are symptomatic. The symptoms mainly include abdominal pain, hematochezia, nausea and vomiting.After the procedure, the time delay between the stent implantation and disappearance of these symptoms are documented.	12 months post-procedure
Secondary	Recurrence	New dissection in the superior mesenteric artery	12 months post-procedure