Trial record 1 of 12 for:
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II (ADVISEII)
This study has been completed.
Information provided by (Responsible Party):
First received: November 16, 2012
Last updated: August 5, 2014
Last verified: August 2014
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)
||Observational Model: Case-Only
Time Perspective: Prospective
||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.
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient receiving a standard of care FFR measurment in the cath lab setting.
- - 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)
- - 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%
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01740895
||Javier Escaned, MD
||Hospital Cl¡nico San Carlos Madrid Spain
||Amir Lerman, MD
||Mayo Clinic Rochester MN USA
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 16, 2012
||August 5, 2014
||United States: Institutional Review Board