Stent Implantation for Patients With SIDSMA

Prospective Observational Cohort Study in Patients With SIDSMA Treated With Stents

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03916965

Enrollment

102

Registered

2019-04-16

Start date

2019-04-01

Completion date

2023-12-30

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dissection of the Superior Mesenteric Artery

Keywords

dissection of the superior mesenteric artery, patency of stents, remodeling

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patency of stents deployed in the superior mesenteric artery	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	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.

Secondary

Measure	Time frame	Description
Relief of symptoms	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.
Recurrence	12 months post-procedure	New dissection in the superior mesenteric artery

Countries

China

Outcome results