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ADVISEII: ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

Sponsor
Volcano Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01740895
Collaborator
(none)
818
Enrollment
44
Locations
6
Duration (Months)
18.6
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    818 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Hemodynamic Severity [at the time of study procedure- 1 day]

      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.

    Secondary Outcome Measures

    1. Specificity [at the time of study procedure- 1 day]

      Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%

    Other Outcome Measures

    1. Sensitivity [at the time of study procedure- 1 day]

      Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chandler Regional Medical Center Chandler Arizona United States 85224
    2 Mercy Gilbert Medical Center Gilbert Arizona United States 85297
    3 Coloado Heart and Vascular/St Anthony's Lakewood Colorado United States 80228
    4 Cardiovascular Research of Florida Gainesville Florida United States 32605
    5 North Florida regional Medical center Gainsville Florida United States 32605
    6 Baptist Cardiac & Vascular Institute Miami Florida United States 33176
    7 Winter Haven Hospital Winter Haven Florida United States 33881
    8 St Johns Hospital/ Prairie Education and Research Springfield Illinois United States 62701
    9 University of Minnesota Minneapolis Minnesota United States 55455
    10 St. Marys Hospital/ MAYO Clinic Rochester Minnesota United States 55902
    11 Regions Hospital Heart Center St Paul Minnesota United States 55101
    12 Washington University St Louis Missouri United States 63110
    13 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
    14 Stony Brook Medicine Stony Brook New York United States 11794
    15 University of North Carolina Hospital Chapel Hill North Carolina United States 27599
    16 Duke University Hospital Durham North Carolina United States 27705
    17 East Carolina University/ Pitt County Hospital Greenville North Carolina United States 27835
    18 Wake Heart research/ Rex Hospital Raleigh North Carolina United States 27607
    19 Wake Heart research/ Wake Medical Center Raleigh North Carolina United States 27610
    20 Forsyth Medical Center Winston-Salem North Carolina United States 27103
    21 Geisinger Medical Center Danville Pennsylvania United States 17822
    22 UPMC Hamot Erie Pennsylvania United States 16550
    23 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    24 Allegheny General Pittsburgh Pennsylvania United States 15212
    25 Medical University of South Carolina Charleston South Carolina United States 29425
    26 VA Charleston (RALPH H. JOHNSON VA MEDICAL CENTER) Charleston South Carolina United States 29425
    27 Greenville Memorial Hospital Greenville South Carolina United States 29605
    28 Wellmont Holston Valley Medical center Kingsport Tennessee United States 37660
    29 Sentara Health/Norfolk General Hospital Norfolk Virginia United States 23507
    30 Auora St Lukes Milwaukee Wisconsin United States 53233
    31 Victoria Heart Institute Foundation Victoria British Columbia Canada
    32 Al Dorrah Cairo Egypt
    33 Kerckhoff Klinik Bad Nauheim Bad Nauheim Germany
    34 AMC Amsterdam Amsterdam Netherlands
    35 Breda Amphia Ziekenhuis Breda Netherlands
    36 Medische Spectrum Twente Enschede Netherlands
    37 ERASMUS MC Rotterdam Rotterdam Netherlands
    38 Jagiellonian University, Institute of Cardiology Krakow Poland
    39 MSWiA Warszawa Woloska Warsaw Poland
    40 Polikliniką SP ZOZ we Wrocławiu Wroclaw Poland
    41 Hospital Universitario San Juan Alicante Spain
    42 Hospital Universitario La Paz de Madrid Madrid Spain
    43 Hospital Cl¡nico San Carlos Marid Spain
    44 Liverpool Heart and Chest Hospital Liverpool United Kingdom

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Volcano Corporation
    ClinicalTrials.gov Identifier:
    NCT01740895
    Other Study ID Numbers:
    • PFC-001
    First Posted:
    Dec 4, 2012
    Last Update Posted:
    Aug 6, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Aug 6, 2014