RecruitingNCT05312164

Physio-Anatomy Clinical Data Collection Study

Sponsor

Gentuity, LLC

Enrollment

150 participants

Start Date

Mar 14, 2022

Study Type

OBSERVATIONAL

Conditions

Coronary Stenosis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Angiography, a medical device called FFR Pressure Wire, and others for people with coronary stenosis. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHF-OCT Imaging

Subjects undergo HF-OCT imaging of stenosed coronary arteries

DEVICEFFR Pressure Wire

Subjects undergo FFR physiology assessment of stenosed coronary arteries

DEVICEAngiography

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

View Full Details on ClinicalTrials.gov

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NCT05312164

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