Impact of Interventional Revascularization on the Physiological Assessment of Bystander Coronary Lesions by FFR

Friedrich-Alexander-Universität Erlangen-Nürnberg160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Coronary Artery Disease

Interventions

Hemodynamic Evaluation of Remote Lesion before & after PCI of Index LesionDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Steigerwaldklinik Burgebrach

Burgebrach, Germany

Department of Medicine 1 - Cardiology, Nephrology, Intensive Care and Rhythmology, St. Johannes Hospital Dortmund

Dortmund, Germany

Deparment of Medicine 2 - Cardiology and Angiology, Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, Germany

Outcomes

Primary Outcomes

ΔFFR

Difference between fractional flow reserve measurements in the remote lesion after and before percutaneous coronary intervention of the index lesion

Time frame: Baseline

Change in Hemodynamic Classification by FFR

Change in hemodynamic classification of the remote lesion with fractional flow reserve after percutaneous coronary intervention of the index lesion

Time frame: Baseline

Secondary Outcomes

ΔNHPR

Difference between non-hyperemic pressure ratio measurements in the remote lesion after and before percutaneous coronary intervention of the index lesion

Time frame: Baseline

Change in Hemodynamic Classification by NHPR

Change in hemodynamic classification of the remote lesion with non-hyperemic pressure ratios after percutaneous coronary intervention of the index lesion

Time frame: Baseline