Coronary Artery Disease
Conditions
Keywords
Intracoronary Pressure Measurement, Fractional Flow Reserve (FFR), Instantaneous Wave-Free Ratio (iFR), Resting Full-Cycle Ratio (RFR), Chronic Coronary Syndrome (CCS), Cardiology
Brief summary
The ABC-FFR trial examines the understudied hemodynamic interaction between parallel coronary stenoses, as the physiological impact of treating one lesion on the pressure indices of lesions in separate parallel branches is not yet fully understood. This prospective, multicenter study enrolls patients scheduled for percutaneous coronary intervention (PCI) of a designated index lesion who also present with a concurrent remote stenosis in a parallel coronary artery. It evaluates potential changes in fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) measurements within the remote lesion both before and after the index lesion is revascularized.
Interventions
DIAGNOSTIC_TESTHemodynamic Evaluation of Remote Lesion before & after PCI of Index Lesion
Initial hemodynamic evaluation of the remote, parallel lesion, followed by the planned percutaneous coronary intervention of the index lesion, and a final hemodynamic reevaluation of the remote lesion
Sponsors
University of Erlangen-Nürnberg Medical School
University Hospital Erlangen
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Scheduled percutaneous coronary intervention for at least one coronary lesion (as indicated by evidence of myocardial ischemia on non-invasive stress imaging, an angiographic stenosis severity \>90% diameter stenosis, or an hemodynamically significant intracoronary pressure measurement) * Additional stenosis of ≥ 30% diameter stenosis in a parallel coronary artery anatomically suitable for wire-based intracoronary pressure assessment
Exclusion criteria
* ST-elevation myocardial infarction * Non-ST-elevation myocardial infarction with immediate invasive strategy recommended by current ESC guidelines (e.g. due to hemodynamic instability, cardiogenic shock, acute heart failure presumed secondary to ongoing myocardial ischemia, recurrent or ongoing chest pain refractory to medical treatment, or life-threatening arrhythmias or cardiac arrest after presentation) * Acute totally occluded coronary artery * Unsuitability for intracoronary measurement of FFR (e.g. due to contraindications for the administration of adenosine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemodynamic Classification by FFR | Baseline | Change in hemodynamic classification of the remote lesion with fractional flow reserve after percutaneous coronary intervention of the index lesion |
| ΔFFR | Baseline | Difference between fractional flow reserve measurements in the remote lesion after and before percutaneous coronary intervention of the index lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔNHPR | Baseline | Difference between non-hyperemic pressure ratio measurements in the remote lesion after and before percutaneous coronary intervention of the index lesion |
| Change in Hemodynamic Classification by NHPR | Baseline | Change in hemodynamic classification of the remote lesion with non-hyperemic pressure ratios after percutaneous coronary intervention of the index lesion |
Countries
Germany
Outcome results
None listed