This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).
DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.
Study Type
OBSERVATIONAL
Enrollment
500
iFR pullback assessment post angiographically successful PCI
Number of Participants With Residual Ischemia (iFR <0.90)
Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography.
Time frame: end of procedure/intervention
Cardiac Events
Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI
Time frame: 12 months
Target Vessel Failure
Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization
Time frame: 12 months
Quality of Life Change From Baseline to 12 Months Follow-up
Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months). Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score. Outcome is the change in score from baseline to 12 months follow-up.
Time frame: 12 months
Cardiac Mortality
All-cause and cardiac mortality at one year
Time frame: 12 months
Target Vessel MI
Target vessel Myocardial infarction at one year
Time frame: 12 month
Target Vessel Revascularization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VA Medical Center
Long Beach, California, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
Emory University Hospital
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Rockford CV Associates
Rockford, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
South Side Hospital
Bay Shore, New York, United States
...and 18 more locations
Ischemia-driven target vessel revascularization at one year
Time frame: 12 month
Recurrent Ischemia
Recurrent ischemia at one-year
Time frame: 12 month
Correlation Between iFR and Angiographic Visual Interpretation
Correlation between iFR \<0.90 and coronary stenosis \>50% assessed by visual interpretation. This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject. An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography. Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR \<0.90 and coronary stenosis \>50% assessed by visual interpretation the correlation is 1).
Time frame: at the end of the procedure/intervention
Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI
Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI
Time frame: Procedural
Differentiation
Differentiation of the cause for impaired iFR
Time frame: End of procedure /intervention
Delta iFR
Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be \<0.90. An OR \> 1 means greater odds that the post-PCI iFR is \<0.90, OR = 1 means there is no association, and OR \< 1 means there is a lower odds that the post-PCI iFR is \<0.90.
Time frame: at the end of the procedure/intervention