ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II (ADVISEII)
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To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)
A Prospective, Observational, Non-randomized, Double Blind, Global, Multi-center Registry With an Adaptive Design, Investigating the Diagnostic Utility of Instantaneous Wave-free Ratio™ (iFR®) in Assessing Coronary Stenosis Relevance.
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Ages Eligible for Study:
18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient receiving a standard of care FFR measurment in the cath lab setting.
- Patient must be > 18 and < 85 years of age
Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
Eligible for coronary angiography and/or percutaneous coronary intervention
Coronary artery disease with at least 1 or more visually assessed coronary stenoses (>40% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
Stable angina or acute coronary syndromes (non-culprit vessels only and outside of primary intervention during acute myocardial infarction)
- Known contraindication to adenosine administration
Implanted temporary or permanent artificial pacemakers, Left Bundle Branch Block (LBBB), 1st and 2nd degree AV Block
STEMI or non STEMI within 48 hours of procedure
Any contraindications for FFR interrogation or percutaneous coronary intervention (PCI) as determined by the investigator
Severe vessel tortuosity and/or severe calcification by angiogram
Significant valvular pathology (moderate or severe AS/AR/MS/MR)
Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Weight >200kg (441 lbs.)
Hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) balloon pump
Significant hepatic disease, renal disease, lung disease (pulmonary chronic pulmonary obstructive disease) and/or malignant disease with unfavorable prognosis or presenting with abnormal serum laboratory values that the physician believes is clinically significant
Contraindication to antithrombotic regimen or anticoagulation therapy
History of or known reaction or sensitivity to contrast agent and is unable to be pre-medicated
Left main stenosis, tandem stenosis separated by more than 5 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis), or total occlusions
Known Left ventricular ejection fraction (LVEF) <30%