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: August 5, 2014
Last verified: August 2014

November 16, 2012
August 5, 2014
December 2012
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01740895 on ClinicalTrials.gov Archive Site
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%
Same as current
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%
Same as current
 
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
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)

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Cardiovascular Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
818
June 2013
June 2013   (final data collection date for primary outcome measure)

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%
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   United States,   Netherlands,   Spain,   Poland,   Germany,   United Kingdom,   Canada
 
NCT01740895
PFC-001
No
Volcano Corporation
Volcano Corporation
Not Provided
Principal Investigator: Javier Escaned, MD Hospital Cl¡nico San Carlos Madrid Spain
Principal Investigator: Amir Lerman, MD Mayo Clinic Rochester MN USA
Volcano Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP