Natural History of Asymptomatic Superior Mesenteric Arter... | NCT04785105

Studies
Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.

NCT04785105

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Mar 5, 2021Actual

Enrollment

77Actual

Phase

Not provided

Conditions

Stenosis

Interventions

No intervention

Countries

France

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Jun 22, 2020

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 5, 2021Actual

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

Mar 4, 2021

Last Update Posted Date

Mar 5, 2021Actual

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

The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

Detailed Description

BACKGROUND: The benefit of preventive treatment for SMA stenosis remains uncertain. The latest guidelines remain unclear given the lack of data in the literature.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with isolated SMA stenosis		patient with isolated SMA stenosis on initial scanner	Other: No intervention
patient with both SMA stenosis and CA or/and IMA stenosis		patient with both SMA stenosis and CA or/and IMA stenosis on initial scanner	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	patient with both SMA stenosis and CA or/and IMA stenosis patient with isolated SMA stenosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of mesenteric disease defined as acute mesenteric ischemia or chronic mesenteric ischemia.		4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with isolated >70% SMA stenosis
patients with both SMA stenosis and CA or/and IMA >70% stenosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupement Hospitalier Est		Bron		69500	France

Condition Browse Module

MeSH Terms

ID	Term
D003251	Constriction, Pathologic

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided