ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II (ADVISEII)

Volcano

Status: Completed

Conditions: Cardiovascular Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01740895

PFC-001

Details and patient eligibility

About

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)

Enrollment: 818 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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%