Elucidate Vasodilatory Capacity From Histology-Defined An... | NCT05524896

Studies
Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography

NCT05524896

Sponsor

Elucid Bioimaging Inc.

Status

Completed

Last Update Posted

Sep 8, 2022Actual

Enrollment

302Actual

Phase

Not provided

Conditions

Vascular Diseases

Interventions

ElucidVivo

Countries

Not provided

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

Sep 2022

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

Jan 1, 2017Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

Jul 13, 2022Actual

First Submitted Date

Aug 30, 2022

First Submission Date that Met QC Criteria

Aug 30, 2022

First Posted Date

Sep 1, 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

Sep 5, 2022

Last Update Posted Date

Sep 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Elucid Bioimaging Inc.INDUSTRY

Collaborators

Name	Class
St. Francis Medical Center, New Jersey	OTHER
The Christ Hospital	OTHER
Medical University of South Carolina	OTHER
Mie University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.

Detailed Description

Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.

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

302Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low FFR		Invasive FFR value <= 0.8	Device: ElucidVivo
High FFR		Invasive FFR value > 0.8	Device: ElucidVivo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ElucidVivo	Device	Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)	High FFR Low FFR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity	the ability of a test to correctly identify patients with low FFR	1 day
Specificity	the ability of a test to correctly identify people without low FFR	1 day

Secondary Outcomes

Measure	Description	Time Frame
Average Error	Difference of noninvasive result - invasive result	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
CCTA was no more than 60 days earlier (and not later)

Exclusion Criteria:

Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)

Accepts Healthy Volunteers

Not provided

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

Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew J Buckler	Elucid Bioimaging Inc.	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33529657	Background	Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.