ADVISE II - Appendix - JACC: Cardiovascular Interventions

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ADVISE II - Appendix
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.)
1
-
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 premedicated
-
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%
Participating centres and site principal investigators
Al-Dorrah Heart Care, Egypt
A. Khashaba
Allegheny-Singer Research Institute, USA
D. Lasorda
Amsterdam Medical Center, NL
J. Piek
Amphia Ziekenhuis, NL
M. Meuwissen
AtlantiCare Regional Medical Center, USA
H. Levite
Aurora St. Luke's Medical Center, USA
S. Allaqaband
Baptist Hospital of Miami/Baptist Cardiac and Vascular Inst, USA
J. Roberts
Chandler Regional Medical Center
G. Nseir
Gilbert Medical Center, USA
G. Nseir
2
Duke University, USA
S. Jones
Emory University, USA
H. Samady
Erasmus Medical Center, NL
R. van Geuns
Fairview, University of Minn, USA
G. Raveendran
Forsyth Medical Center, USA
R. Preli
Geisinger Clinic Danville, USA
J. Blankenship
Greenville Memorial Hospital, USA
J. Baucum
UPMC Hamot, USA
Q. Orlando
Hosp. Clinico San Carlos, Spain
J. Escaned
Hosp. Univ San Juan, Alicante, Spain
R. Palop
Hosp. Univ. La Paz, Madrid, Spain
R. Moreno
Szpitala Uniwersyteckiego w Krakowie, Poland
J. Legutko
Kerckhoff-Klinik, Germany
H. Möllman
LLC and North Florida Hospital
M. Tulli
Liverpool Heart & Chest Hospital NHS, UK
R. Stables
Mayo Clinic, USA
R. Gulati
Medical University of South Carolina, USA
E. Powers
MSWiA Warsawza Woloska, Poland
R. Gil
Cardiovascular Research of North Florida, USA
M. Tulli
East Carolina University- Pitt County Memorial Hospital, USA
B. Carrabus
Polikliniką SP ZOZ we Wrocławiu, Poland
K. Reczuch
Regions Hospital, USA
J. Brechtken
Rex Hospital
J. Schneider
Victoria Heart Institute, Canada
A. Della Siega
Sentara Cardiovascular Research Institute, USA
P. Mahoney
Colorado Heart and Vascular, PC- St. Anthony Hospital, USA
J. Altman
3
St. John's Hospital, USA
G. Mishkel
State University of New York, USA
A. Jeremias
Medisch Spectrum Twente, NL
C. von Birgelen
University of North Carolina at Chapel Hill, USA
P. Kaul
Ralph H. Johnson VA Medical Center, USA
V. Fernandes
Wake Heart Research, LLC, USA
J. Schneider
Washington University - Barnes Jewish, USA
H. Kurz
Wellmont Holston Valley Medical Center, USA
M. Mayhew
Winter Haven Hospital, USA
Z. Tai
4
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