Phase
Condition
Coronary Artery Disease
Treatment
HF-OCT Imaging
FFR Pressure Wire
Angiography
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 thecardiac catheter lab with the intent to perform a physiological assessment for denovo lesions with stenosis, if clinically indicated.
Exclusion
Exclusion Criteria:
Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cathlab 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 timeof screening.
Patient is pregnant.
Patient is currently enrolled in another clinical study that may impact the resultsof this study.
Patient has other co-morbid condition(s) that, in the opinion of the Investigator,could limit their
Study Design
Study Description
Connect with a study center
Veteran's Administration Palo Alto
Palo Alto, California 94304
United StatesActive - Recruiting
Tampa General Hospital
Tampa, Florida 33606
United StatesActive - Recruiting
Atlanta VA Medical Center
Decatur, Georgia 30033
United StatesActive - Recruiting
Baptist Health
Lexington, Kentucky 40503
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Minneapolis VA Medical Center
Minneapolis, Minnesota 55417
United StatesActive - Recruiting
The Christ Hospital
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
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