Physio-Anatomy Clinical Data Collection Study | NCT05312164

Studies
Physio-Anatomy Clinical Data Collection Study

NCT05312164

Sponsor

Gentuity, LLC

Status

Recruiting

Last Update Posted

Mar 20, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Coronary Stenosis

Interventions

HF-OCT Imaging
FFR Pressure Wire
Angiography

Countries

United States

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

Mar 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

Mar 14, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 18, 2022

First Submission Date that Met QC Criteria

Mar 31, 2022

First Posted Date

Apr 5, 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

Mar 19, 2025

Last Update Posted Date

Mar 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Detailed Description

These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include:

A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters.
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Candidates for PCI		Patients undergoing diagnostic cardiac catheterization/PCI.	Device: HF-OCT Imaging Device: FFR Pressure Wire Device: Angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HF-OCT Imaging	Device	Subjects undergo HF-OCT imaging of stenosed coronary arteries	Candidates for PCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Collection of angiography images, HF-OCT images, and FFR pressure wire data	There are no efficacy or safety outcomes in this study. This study is a simple data collection study to help the sponsor develop next-generation HF-OCT software. Pressure wire data will be paired with HF-OCT images and angiography images for analysis to determine if the HF-OCT imaging technology can predict FFR physiology information from the OCT pullback.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >18 years of age.
Patients provide written informed consent.
Clinical presentation consistent with suspected coronary disease.
Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.

Exclusion Criteria:

Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
Contraindication for FFR examination or administration of vasodilators.
Bacteremia or sepsis.
Major coagulation system abnormalities.
Severe hemodynamic instability or shock.
Heart Failure NYHA Class IV.
Severe valvular heart disease.
Prior heart transplant.
Acute renal failure based on diagnostic practice of the treating physician at time of screening.
Patient is pregnant.
Patient is currently enrolled in another clinical study that may impact the results of this study.
Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their

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

Patients who are candidates for PCI who already have a scheduled visit to the cardiac cath lab.

Sampling Method

Non-Probability Sample

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis