Physio-Anatomy Clinical Data Collection Study

Coronary Stenosis Clinical Trial

Official title:

Physio-Anatomy Clinical Data Collection Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312164
• Other study ID #: 003785
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Gentuity, LLC
• Contact: Arjun Bhat, MD, MBA
• Phone: 978-202-4108
• Email: abhat[@]gentuity.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• HF-OCT Imaging
Subjects undergo HF-OCT imaging of stenosed coronary arteries
• FFR Pressure Wire
Subjects undergo FFR physiology assessment of stenosed coronary arteries
• Angiography
Subjects undergo angiography imaging of stenosed coronary arteries

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Christ Hospital	Cincinnati	Ohio
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota
United States	Veteran's Administration Palo Alto	Palo Alto	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gentuity, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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