ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II (ADVISEII)

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.

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)

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease

• Study Type: Observational
• Enrollment (Actual): 818

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada
      • Victoria Heart Institute Foundation
• Egypt
  • Cairo, Egypt
    • Al Dorrah
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff Klinik Bad Nauheim
• Netherlands
  • Amsterdam, Netherlands
    • AMC Amsterdam
  • Breda, Netherlands
    • Breda Amphia Ziekenhuis
  • Enschede, Netherlands
    • Medische Spectrum Twente
  • Rotterdam, Netherlands
    • Erasmus MC Rotterdam
• Poland
  • Krakow, Poland
    • Jagiellonian University, Institute of Cardiology
  • Warsaw, Poland
    • MSWiA Warszawa Woloska
  • Wroclaw, Poland
    • Polikliniką SP ZOZ we Wrocławiu
• Spain
  • Alicante, Spain
    • Hospital Universitario San Juan
  • Madrid, Spain
    • Hospital Universitario La Paz de Madrid
  • Marid, Spain
    • Hospital Cl¡nico San Carlos
• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center
    • Gilbert, Arizona, United States, 85297
      • Mercy Gilbert Medical Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Coloado Heart and Vascular/St Anthony's
  • Florida
    • Gainesville, Florida, United States, 32605
      • Cardiovascular Research of Florida
    • Gainsville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Miami, Florida, United States, 33176
      • Baptist Cardiac & Vascular Institute
    • Winter Haven, Florida, United States, 33881
      • Winter Haven Hospital
  • Illinois
    • Springfield, Illinois, United States, 62701
      • St Johns Hospital/ Prairie Education and Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55902
      • St. Marys Hospital/ MAYO Clinic
    • St Paul, Minnesota, United States, 55101
      • Regions Hospital Heart Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Pomona, New Jersey, United States, 08240
      • AtlantiCare Regional Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Hospital
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital
    • Greenville, North Carolina, United States, 27835
      • East Carolina University/ Pitt County Hospital
    • Raleigh, North Carolina, United States, 27607
      • Wake Heart research/ Rex Hospital
    • Raleigh, North Carolina, United States, 27610
      • Wake Heart research/ Wake Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Erie, Pennsylvania, United States, 16550
      • UPMC Hamot
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29425
      • VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER)
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Health/Norfolk General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Auora St Lukes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient receiving a standard of care FFR measurment in the cath lab setting.

Description

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%

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Severity	Percentage of stenosis properly classified in terms of hemodynamic severity by iFR values ≤0.85 and ≥0.94. Hemodynamic severity will be established with an FFR value ≤ 0.80.	at the time of study procedure- 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%	at the time of study procedure- 1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%	at the time of study procedure- 1 day

Collaborators and Investigators

• Sponsor: Volcano Corporation
• Investigators: Principal Investigator: Javier Escaned, MD, Hospital Cl¡nico San Carlos Madrid Spain; Principal Investigator: Amir Lerman, MD, Mayo Clinic Rochester MN USA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PFC-001