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

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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%

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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