Actively Recruiting
Physio-Anatomy Clinical Data Collection Study
Led by Gentuity, LLC · Updated on 2025-03-20
150
Participants Needed
6
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Physio-Anatomy Clinical Data Collection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 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 will not qualify if you...
- 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 participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Veteran's Administration Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
2
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
3
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
6
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
A
Arjun Bhat, MD, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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