Phase
Condition
Occlusions
Heart Disease
Myocardial Ischemia
Treatment
Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Suspected ischemic heart disease and is referred to undergo clinically indicatedinvasive coronary angiography
No obstructive coronary artery disease (CAD) as defined by operator visualassessment with (1) angiographically normal coronary arteries OR (2) non-obstructiveCAD with angiographic stenosis < 50%, or greater than or equal to 50 but < 70% withFFR greater than or equal to 0.81 or RFR greater than or equal to 0.90
Willing to comply with specified follow-up evaluations. The participant or legallyauthorized representative has been informed of the nature of the study, agrees toits provisions, and has been provided written informed consent approved by theappropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion
Exclusion Criteria:
Pregnant or nursing
Any myocardial infarction at index presentation or within 90 days prior toenrollment, defined as any electrocardiogram diagnostic for myocardial infarction ORelevation in serum troponin greater than the upper limit of the site-definedreference range
Known left ventricular ejection fraction < 50% or cardiogenic shock requiringpressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, leftventricular assist device, other temporary cardiac support blood pump)
Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) or dialysisat the time of screening
Prior percutaneous coronary intervention
Planned percutaneous coronary intervention (PCI)
Prior coronary artery bypass graft surgery
Prior ST-elevation myocardial infarction
History of hypertrophic cardiomyopathy
History of infiltrative heart disease (e.g., cardiac amyloidosis)
New York Heart Association Class IV congestive heart failure
Severe mitral regurgitation
Severe aortic stenosis
Severe pulmonary hypertension (Mean pulmonary artery pressure greater than or equalto 35mmHg or echocardiographic right ventricular systolic pressure greater than orequal to 60mmHg)
Known history of unrepaired or repaired congenital heart disease
Past or pending heart transplant, or on the waiting list for organ transplant
Known other medical illness or known history of substance abuse that may causenon-compliance with the protocol, or is associated with a life expectancy of lessthan 1 year
Current or planned participation in a study of an investigational therapy
Angiographic stenosis in any major epicardial vessel ≥ 70% by visual estimate
Angiographic stenosis in any major epicardial vessel greater than or equal to 50%and < 70% by visual estimate with FFR less than or equal to 0.80 or RFR less than orequal to 0.89
Study Design
Study Description
Connect with a study center
UCLA Health
Los Angeles, California 90095
United StatesSite Not Available
Stanford Hospital
Stanford, California 94305
United StatesSite Not Available
UCLA Health
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Stanford Hospital
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06520
United StatesSite Not Available
Yale University
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06520
United StatesSite Not Available
Northeast Georgia Medical Center
Gainesville, Georgia 30501
United StatesSite Not Available
Northeast Georgia Medical Center
Gainesville 4196586, Georgia 4197000 30501
United StatesSite Not Available
New York Presbyterian-Brooklyn Methodist Hospital
Brooklyn, New York 11215
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10010
United StatesSite Not Available
New York Presbyterian-Brooklyn Methodist Hospital
Brooklyn 5110302, New York 5128638 11215
United StatesSite Not Available
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10010
United StatesSite Not Available
The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available

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