Minneapolis, Minnesota 55455

  • Cardiovascular Disease

Purpose:

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)


Criteria:

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%


NCT ID:

NCT01740895


Primary Contact:

Principal Investigator
Javier Escaned, MD
Hospital Cl¡nico San Carlos Madrid Spain


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 31, 2021

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