ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

Completed

Conditions studied: Cardiovascular Disease

In brief

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)

Key facts

Study ID

NCT01740895

Run by

Volcano Corporation

People needed

818

Starts

2012-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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)

You may not qualify if…

• - 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%

Where it is running

• Chandler Regional Medical Center — Chandler, Arizona, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Coloado Heart and Vascular/St Anthony's — Lakewood, Colorado, United States
• Cardiovascular Research of Florida — Gainesville, Florida, United States
• North Florida regional Medical center — Gainsville, Florida, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Winter Haven Hospital — Winter Haven, Florida, United States
• St Johns Hospital/ Prairie Education and Research — Springfield, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• St. Marys Hospital/ MAYO Clinic — Rochester, Minnesota, United States
• Regions Hospital Heart Center — Saint Paul, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• AtlantiCare Regional Medical Center — Pomona, New Jersey, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• University of North Carolina Hospital — Chapel Hill, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• East Carolina University/ Pitt County Hospital — Greenville, North Carolina, United States
• Wake Heart research/ Rex Hospital — Raleigh, North Carolina, United States
• Wake Heart research/ Wake Medical Center — Raleigh, North Carolina, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• UPMC Hamot — Erie, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Allegheny General — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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