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Stent Implantation for Patients With SIDSMA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916965
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

Study Description
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Brief 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.

Condition or disease
Dissection of the Superior Mesenteric Artery

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 2 years after patients have received stents.
Study Design
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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Patency of stents deployed in the superior mesenteric artery [ Time Frame: 24 months post-procedure ]
    The patency of stents deployed in the superior mesenteric artery shall be evaluated via computed tomographic angiography

  2. Remodeling of the superior mesenteric artery [ Time Frame: 24 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.


Secondary Outcome Measures :
  1. Relief of symptoms [ Time Frame: 24 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.

  2. Recurrence [ Time Frame: 24 months post-procedure ]
    New dissection or aneurysm formation in the superior mesenteric artery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916965


Locations
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China, Zhejiang
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Ziheng Wu Zhejiang University
More Information
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Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03916965    
Other Study ID Numbers: 2019.62
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Zhejiang University:
dissection of the superior mesenteric artery
patency of stents
remodeling