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Completed

NCT Number: NCT01740895

ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II

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)

Completed

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Victoria Heart Institute Foundation, Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. Hemodynamic Severity

    Time frame: 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 outcomes

  1. Specificity

    Time frame: 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 outcomes

  1. Sensitivity

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Volcano Corporation

Industry

Registry information

Official study 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.

Acronym: ADVISEII

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2012
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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