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RECRUITING
NCT05312164

Physio-Anatomy Clinical Data Collection Study

Sponsor: Gentuity, LLC

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2022-03-14

Completion Date

2025-12-31

Last Updated

2025-03-20

Healthy Volunteers

Not specified

Interventions

DEVICE

HF-OCT Imaging

Subjects undergo HF-OCT imaging of stenosed coronary arteries

DEVICE

FFR Pressure Wire

Subjects undergo FFR physiology assessment of stenosed coronary arteries

DEVICE

Angiography

Subjects undergo angiography imaging of stenosed coronary arteries

Locations (6)

Veteran's Administration Palo Alto

Palo Alto, California, United States

Tampa General Hospital

Tampa, Florida, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

The Christ Hospital

Cincinnati, Ohio, United States