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Physio-Anatomy Clinical Data Collection Study
Sponsor: Gentuity, LLC
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
Conditions
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
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