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

NCT07314879 | Completed

• 1 other identifier: 12_21 Bc
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Keywords

Intracoronary Pressure Measurement; Fractional Flow Reserve (FFR); Instantaneous Wave-Free Ratio (iFR); Resting Full-Cycle Ratio (RFR); Chronic Coronary Syndrome (CCS); Cardiology

Outcome Measures

Primary Outcomes (2)

• ΔFFR

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

  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

  Baseline

Secondary Outcomes (2)

• ΔNHPR

  Baseline

• Change in Hemodynamic Classification by NHPR

  Baseline

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were scheduled for percutaneous coronary intervention of at least one coronary index stenosis and had at least one additional remote stenosis in a parallel coronary artery

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: collaborator
• University Hospital Erlangen: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (3)

Steigerwaldklinik Burgebrach

Burgebrach, 96138, Germany

Location

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

Dortmund, 44137, Germany

Location

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

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: June 10, 2020
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)