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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Volcano Corporation
ClinicalTrials.gov Identifier:
NCT01740895
First received: November 16, 2012
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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
Cardiovascular Disease

Study Type: Observational
Study Design: 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.

Further study details as provided by Volcano Corporation:

Primary Outcome Measures:
  • Hemodynamic Severity [ Time Frame: at the time of study procedure- 1 day ] [ Designated as safety issue: No ]
    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:
  • Specificity [ Time Frame: at the time of study procedure- 1 day ] [ Designated as safety issue: No ]
    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:
  • Sensitivity [ Time Frame: at the time of study procedure- 1 day ] [ Designated as safety issue: No ]
    Minimum iFR exclusion ranges around iFR 0.89 in which iFR and FFR agreement is equal to or greater than 80% and 90%


Enrollment: 800
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740895

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

No publications provided

Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT01740895     History of Changes
Other Study ID Numbers: PFC-001
Study First Received: November 16, 2012
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014