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

  Show 44 Study Locations
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