Status:
RECRUITING
Physio-Anatomy Clinical Data Collection Study
Lead Sponsor:
Gentuity, LLC
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laborat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05312164
Start Date
March 14 2022
End Date
December 31 2025
Last Update
March 20 2025
Active Locations (6)
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1
Veteran's Administration Palo Alto
Palo Alto, California, United States, 94304
2
Tampa General Hospital
Tampa, Florida, United States, 33606
3
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215