Physio-Anatomy Clinical Data Collection Study

NCT05312164 | Recruiting FDA Device

• 1 other identifier: 003785
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Candidates for PCI

Patients undergoing diagnostic cardiac catheterization/PCI.

Device: HF-OCT Imaging; Device: FFR Pressure Wire; Device: Angiography

Interventions

HF-OCT Imaging DEVICE

Subjects undergo HF-OCT imaging of stenosed coronary arteries

Candidates for PCI

FFR Pressure Wire DEVICE

Subjects undergo FFR physiology assessment of stenosed coronary arteries

Candidates for PCI

Angiography DEVICE

Subjects undergo angiography imaging of stenosed coronary arteries

Candidates for PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gentuity, LLC: lead

Study Sites (6)

Veteran's Administration Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Arjun Bhat, MD, MBA

CONTACT

978-202-4108; abhat@gentuity.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 5, 2022
• Study Start: March 14, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (6)