Arch Size Study for Anatomical Variations | NCT06235619

Studies
Arch Size Study for Anatomical Variations

NCT06235619

Sponsor

IRCCS San Raffaele

Status

Recruiting

Last Update Posted

May 2, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Aortic Arch
Aneurysm
Dissection, Aortic

Interventions

Not provided

Countries

Italy

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 2025

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

Sep 1, 2024Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Jan 23, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Feb 1, 2024Actual

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 30, 2025

Last Update Posted Date

May 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aortic arch with a common origin of the innominate and left carotid artery (CILCA) prevalence in the general population is 13.6%. Its reputation as a benign anatomical variant has been ultimately shattered by further studies that identified the CILCA arch as a potential marker for thoracic aortic disease (TAD) The aim of this work is to report the CT anatomical characteristics of the aortic arch in subjects with or without aneurysms requiring treatment, in 5 major European cardiovascular centers.

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

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non aneurysm patients		CT anatomical characteristics of the aortic arch in subjects without aneurysms requiring treatment.
Aneurysm patients		CT anatomical characteristics of the aortic arch in subjects withaneurysms requiring treatment.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference from baseline of aortic arch anomalies	record of anatomical variations of the aortic arch	30 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with aortic arch CT scan at investigating centers

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The population of the study is the general population undergoing Angio CT scan both the thoracic aorta

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS San Raffaele Hospital	Recruiting	Milan	Italy	20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000783	Aneurysm
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000094665	Dissection, Blood Vessel
D000094683	Acute Aortic Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided