ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:5/27/2013
Start Date:December 2012
End Date:December 2013
Contact:Eric Ryan, MD
Email:eryan@volcanocorp.com

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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.


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)


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%
We found this trial at
13
sites
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, South Carolina 29425
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Erie, Pennsylvania 16507
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Gainesville, Florida 32605
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Kingsport, Tennessee 37660
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Milwaukee, Wisconsin 53233
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Pittsburgh, Pennsylvania 15212
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Springfield, IL
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Stony Brook, New York 11794
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Winston-Salem, North Carolina 27103
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