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

NCT ID: NCT07314879

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2025-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Hemodynamic 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role collaborator

University Hospital Erlangen

OTHER

Sponsor Role collaborator

Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role lead

Responsible Party

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Johannes Michael Altstidl

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Steigerwaldklinik Burgebrach

Burgebrach, , Germany

Site Status

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

Dortmund, , Germany

Site Status

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

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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12_21 Bc

Identifier Type: -

Identifier Source: org_study_id

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