Recruiting

Observational Study

Sponsor:

Gentuity, LLC

Code:

NCT05312164

Conditions

Coronary Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HF-OCT Imaging

FFR Pressure Wire

Angiography

Study Details

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

Study ID

NCT05312164

Start date

Mar 14, 2022

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Candidates for PCI

Patients undergoing diagnostic cardiac catheterization/PCI.

Interventions

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

Primary outcome measure

  • Collection of angiography images, HF-OCT images, and FFR pressure wire data [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Arjun Bhat, MD, MBA

978-202-4108abhat@gentuity.com

Locations

Veteran's Administration Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

William Fearon, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Thanh Tran

813-844-8544tqtran@usf.edu

Principal Investigator:

Hiram Bezerra, MD

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Principal Investigator:

Gautam Kumar, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Eric A Osborn, MD, PhD

Minneapolis VA Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Principal Investigator:

Alok Sharma, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Jarrod Frizzell, MD

More Information

Sponsor

Gentuity, LLC

Last update posted

Mar 20, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gentuity, LLC on 2025-03-20.