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Completed

NCT Number: NCT07314879

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steigerwaldklinik Burgebrach, Burgebrach, Germany

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Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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

Diagnostic 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

Primary outcomes

  1. ΔFFR

    Time frame: Baseline

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

  2. Change in Hemodynamic Classification by FFR

    Time frame: Baseline

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

Secondary outcomes

  1. ΔNHPR

    Time frame: Baseline

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

  2. Change in Hemodynamic Classification by NHPR

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Collaborators

  • University Hospital Erlangen
  • University of Erlangen-Nürnberg Medical School

Registry information

Official study title

Impact of Interventional Revascularization on the Physiological Assessment of Bystander Coronary Lesions by FFR (ABC-FFR)

Acronym: ABC-FFR

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

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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