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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014