- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314879
Impact of Interventional Revascularization on the Physiological Assessment of Bystander Coronary Lesions by FFR (ABC-FFR)
December 18, 2025 updated by: Johannes Michael Altstidl, Friedrich-Alexander-Universität Erlangen-Nürnberg
Impact of Interventional Revascularization on the Physiological Assessment of Bystander Coronary Lesions by FFR (ABC-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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Burgebrach, Germany, 96138
- Steigerwaldklinik Burgebrach
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Dortmund, Germany, 44137
- Department of Medicine 1 - Cardiology, Nephrology, Intensive Care and Rhythmology, St. Johannes Hospital Dortmund
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Erlangen, Germany, 91054
- Deparment of Medicine 2 - Cardiology and Angiology, Friedrich-Alexander-Universität Erlangen-Nürnberg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ΔFFR
Time Frame: Baseline
|
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
Time Frame: Baseline
|
Change in hemodynamic classification of the remote lesion with fractional flow reserve after percutaneous coronary intervention of the index lesion
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
|
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
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2020
Primary Completion (Actual)
June 26, 2025
Study Completion (Actual)
June 26, 2025
Study Registration Dates
First Submitted
December 18, 2025
First Submitted That Met QC Criteria
December 18, 2025
First Posted (Estimated)
January 2, 2026
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12_21 Bc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Privacy and ethical restrictions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.