Clinical trial NCT01740895: ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient receiving a standard of care FFR measurment in the cath lab setting.

Brief summary: 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)


Eligibility 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%

Primary outcomes:
measure: Hemodynamic Severity
timeFrame: at the time of study procedure- 1 day
Secondary outcomes:
measure: Specificity
timeFrame: at the time of study procedure- 1 day
Other outcomes:
measure: Sensitivity
timeFrame: at the time of study procedure- 1 day
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Lakewood
country: United States
facility: Coloado Heart and Vascular/St Anthony's
state: Colorado
city: Gainesville
country: United States
facility: Cardiovascular Research of Florida
state: Florida
city: Gainsville
country: United States
facility: North Florida regional Medical center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Springfield
country: United States
facility: St Johns Hospital/ Prairie Education and Research
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: St. Marys Hospital/ MAYO Clinic
state: Minnesota
city: St Paul
country: United States
facility: Regions Hospital Heart Center
state: Minnesota
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University/ Pitt County Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart research/ Rex Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart research/ Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical center
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Health/Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Auora St Lukes
state: Wisconsin
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Cairo
country: Egypt
facility: Al Dorrah
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Bad Nauheim
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Breda
country: Netherlands
facility: Breda Amphia Ziekenhuis
city: Enschede
country: Netherlands
facility: Medische Spectrum Twente
city: Rotterdam
country: Netherlands
facility: ERASMUS MC Rotterdam
city: Krakow
country: Poland
facility: Jagiellonian University, Institute of Cardiology
city: Warsaw
country: Poland
facility: MSWiA Warszawa Woloska
city: Wroclaw
country: Poland
facility: Polikliniką SP ZOZ we Wrocławiu
city: Alicante
country: Spain
facility: Hospital Universitario San Juan
city: Madrid
country: Spain
facility: Hospital Universitario La Paz de Madrid
city: Marid
country: Spain
facility: Hospital Cl¡nico San Carlos
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
Study officials:
affiliation: Hospital Cl¡nico San Carlos Madrid Spain
name: Javier Escaned, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic Rochester MN USA
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.