ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

Study Overview
=================
Brief Summary
-----------------
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)

Official Title
-----------------
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.

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 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) Exclusion Criteria: - 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%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Severity | Percentage of stenosis properly classified in terms of hemodynamic severity by iFR values ≤0.85 and ≥0.94. Hemodynamic severity will be established with an FFR value ≤ 0.80. | at the time of study procedure- 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90% | at the time of study procedure- 1 day |