Stent Implantation for Patients With SIDSMA

December 25, 2023 updated by: First Affiliated Hospital of Zhejiang University

Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed as spontaneous isolated dissection of the superior mesenteric artery (SIDSMA) and treated with stents are potential candidates for the study. All participants must meet all inclusion criteria and none of the exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency of stents deployed in the superior mesenteric artery
Time Frame: 12 months post-procedure
The patency of stents deployed in the superior mesenteric artery shall be evaluated via computed tomographic angiography
12 months post-procedure
Remodeling of the superior mesenteric artery
Time Frame: 12 months post-procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of symptoms
Time Frame: 12 months post-procedure
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
Recurrence
Time Frame: 12 months post-procedure
New dissection in the superior mesenteric artery
12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Ziheng Wu, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019.62

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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