ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
NCT ID: NCT01740895
Last Updated: 2014-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
818 participants
OBSERVATIONAL
2012-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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%
18 Years
85 Years
ALL
No
Sponsors
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Volcano Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Javier Escaned, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Cl¡nico San Carlos Madrid Spain
Amir Lerman, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Rochester MN USA
Locations
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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
VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)
Charleston, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Wellmont Holston Valley Medical center
Kingsport, Tennessee, United States
Sentara Health/Norfolk General Hospital
Norfolk, Virginia, United States
Auora St Lukes
Milwaukee, Wisconsin, United States
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
Al Dorrah
Cairo, , Egypt
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, , Germany
AMC Amsterdam
Amsterdam, , Netherlands
Breda Amphia Ziekenhuis
Breda, , Netherlands
Medische Spectrum Twente
Enschede, , Netherlands
ERASMUS MC Rotterdam
Rotterdam, , Netherlands
Jagiellonian University, Institute of Cardiology
Krakow, , Poland
MSWiA Warszawa Woloska
Warsaw, , Poland
Polikliniką SP ZOZ we Wrocławiu
Wroclaw, , Poland
Hospital Universitario San Juan
Alicante, , Spain
Hospital Universitario La Paz de Madrid
Madrid, , Spain
Hospital Cl¡nico San Carlos
Marid, , Spain
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Countries
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References
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Echavarria-Pinto M, van de Hoef TP, Garcia-Garcia HM, de Vries T, Serruys PW, Samady H, Piek JJ, Lerman A, Escaned J; ADVISE II Study Group. Diagnostic Accuracy of Baseline Distal-to-Aortic Pressure Ratio to Assess Coronary Stenosis Severity: A Post-Hoc Analysis of the ADVISE II Study. JACC Cardiovasc Interv. 2015 May;8(6):834-836. doi: 10.1016/j.jcin.2014.12.245. No abstract available.
Escaned J, Echavarria-Pinto M, Garcia-Garcia HM, van de Hoef TP, de Vries T, Kaul P, Raveendran G, Altman JD, Kurz HI, Brechtken J, Tulli M, Von Birgelen C, Schneider JE, Khashaba AA, Jeremias A, Baucum J, Moreno R, Meuwissen M, Mishkel G, van Geuns RJ, Levite H, Lopez-Palop R, Mayhew M, Serruys PW, Samady H, Piek JJ, Lerman A; ADVISE II Study Group. Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). JACC Cardiovasc Interv. 2015 May;8(6):824-833. doi: 10.1016/j.jcin.2015.01.029.
Other Identifiers
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PFC-001
Identifier Type: -
Identifier Source: org_study_id
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