Comparison of Conservative and Endovascular Treatment for... | NCT05342233

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

NCT05342233

Sponsor

Xiangya Hospital of Central South University

Status

Recruiting

Last Update Posted

Apr 22, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Spontaneous Isolated Superior Mesenteric Artery Dissection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2022Estimated

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Apr 10, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2022

Last Update Posted Date

Apr 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

xueguanwaike, Professor, Xiangya Hospital of Central South UniversityPrincipal Investigator

Lead Sponsor

Xiangya Hospital of Central South UniversityOTHER

Collaborators

Name	Class
The First Medical Center of Chinese PLA General Hospital	OTHER
West China Hospital	OTHER
Renmin Hospital of Wuhan University	OTHER
Peking University Shenzhen Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Reintervention rate	Reintervention related to SISMAD after treatments during follow-up period	Follow-up period（ 5 years）
Recurrence rate	SISMAD Recurrence after treatments during follow-up period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang WEI, Ph.D.	Contact	13808482650		weiwangcsu@csu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiangya Hospital of Central South University	Recruiting	Changsha	Hunan		China