Cardiovascular Disease
Conditions
Brief summary
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)
Interventions
None listed
Sponsors
Volcano Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 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% |
Countries
Canada, Egypt, Germany, Netherlands, Poland, Spain, United Kingdom, United States
Outcome results
None listed