Dissection of the Superior Mesenteric ArteryNCT03916965
Stent Implantation for Patients With SIDSMA
An observational study of Dissection of the Superior Mesenteric Artery, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissection of the Superior Mesenteric Artery
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or non-pregnant female over 18 years of age
- Diagnosed as spontaneous isolated dissection of the superior mesenteric artery
- Patients have been successfully treated with stents
- Patients are willing to participate in this study
Who cannot join
- Life expectancy of < 5 years;
- Other surgeries or endovascular treatments have been taken concurrently.
- Elevated serum level
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: 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.
Read the 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.
- Keywords
- dissection of the superior mesenteric artery, patency of stents, remodeling
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post-procedure
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.
Measured: 12 months post-procedure
Secondary outcomes (2)
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.
Measured: 12 months post-procedure
Recurrence
New dissection in the superior mesenteric artery
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dissection of the Superior Mesenteric ArteryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziheng Wu, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916965
- Sponsor's protocol ID
- 2019.62
- Status last verified
- Feb 2023
- First submitted
- 7 Apr 2019
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang Z, Wang B, Shen P, He Y, Wang X, Li D, Shang T, Zhu Q, Zeng Q, Chen T, Zhang H, Qiu C, Wu Z. Endovascular treatment for spontaneous isolated dissection of superior mesenteric artery: a Single-centre prospective study. J Cardiothorac Surg. 2026 Feb 25;21(1):146. doi: 10.1186/s13019-026-03901-8.
PubMed 41742269Qiu C, Wu Z, He Y, Tian L, Zhu Q, Shang T, Zhang H, Li D. Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery. Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD014703. doi: 10.1002/14651858.CD014703.pub2.
PubMed 36074662
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents
- ClinicalTrials.gov ID
- NCT03916965
- Acronym / sponsor ID
- 2019.62
- Keywords
- dissection of the superior mesenteric artery, patency of stents, remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Male or non-pregnant female over 18 years of age
- Diagnosed as spontaneous isolated dissection of the superior mesenteric artery
- Patients have been successfully treated with stents
- Patients are willing to participate in this study
Key exclusion criteria (3 listed)
- Life expectancy of < 5 years;
- Other surgeries or endovascular treatments have been taken concurrently.
- Elevated serum level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
2 secondary outcomes
Relief of symptoms
Time frame: 12 months post-procedure
Recurrence
Time frame: 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 41742269Fang Z, Wang B, Shen P, He Y, Wang X, Li D, Shang T, Zhu Q, Zeng Q, Chen T, Zhang H, Qiu C, Wu Z. Endovascular treatment for spontaneous isolated dissection of superior mesenteric artery: a Single-centre prospective study. J Cardiothorac Surg. 2026 Feb 25;21(1):146. doi: 10.1186/s13019-026-03901-8.
- Derived from this study: PubMed 36074662Qiu C, Wu Z, He Y, Tian L, Zhu Q, Shang T, Zhang H, Li D. Endovascular therapy versus medical treatment for spontaneous isolated dissection of the superior mesenteric artery. Cochrane Database Syst Rev. 2022 Sep 8;9(9):CD014703. doi: 10.1002/14651858.CD014703.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziheng Wu principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissection of the Superior Mesenteric Artery, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of stents deployed in the superior mesenteric artery (time frame: 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.