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 |
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
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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171 Ashley Avenue
Charleston, South Carolina 29425
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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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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