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DECisive Intracoronary Physiology and Imaging in ACS Non-culprit Lesion Evaluation NCT07548554

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Summary

NCT07548554 is an observational clinical trial registered on April 23, 2026, evaluating intracoronary physiology and imaging techniques for assessing and reclassifying non-culprit lesions in patients with acute coronary syndromes. The study examines coronary artery disease using fractional flow reserve and optical coherence tomography under conditions including coronary artery disease, ACS, OCT, and FFR. As an observational registry entry, this trial does not impose compliance obligations on healthcare providers or institutions.

“Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP.”

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What changed

NCT07548554 was added to the ClinicalTrials.gov registry as an observational study examining the use of intracoronary physiology and imaging modalities—specifically fractional flow reserve and optical coherence tomography—in the evaluation of non-culprit lesions among acute coronary syndrome patients. The trial is registered as observational with no specified intervention arms, reflecting a diagnostic assessment study design.

Healthcare institutions and clinical investigators should note that this registry entry represents a research activity rather than a regulatory requirement or compliance mandate. The trial's findings may inform future guideline recommendations regarding the use of invasive intracoronary physiology for intermediate lesion assessment, but no immediate operational changes are required based on this registration alone.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome

Observational NCT07548554 Kind: OBSERVATIONAL Apr 23, 2026

Abstract

Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. This perfusion abnormality most commonly arises from compromise of epicardial coronary artery patency due to stenosis, occlusion, or vasomotor abnormalities. Structural and/or functional alterations in the microcirculation may also contribute to impaired myocardial perfusion.

Conditions in which myocardial perfusion is acutely compromised are classified as acute coronary syndromes (ACS), whereas reversible ischemia developing on a chronic basis is evaluated under the umbrella of chronic coronary syndromes (CCS). In the assessment of epicardial (macrovascular) or microvascular pathologies leading to ischemia in CCS, angiography, a macroscopic lumenographic method, is often insufficient. Intracoronary pressure and flow measurements are required to determine the impact of angiographically detected epicardial lesions on coronary blood flow, perfusion pressure, and consequently myocardial perfusion. These measurements are referred to as invasive intracoronary physiology (IIP).

Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP. Revascularization guided by IIP is associated with reduced mortality and morbidity, ...

Conditions: Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography, Fractional Flow Reserve

Interventions: Intracoronary Physiology, Intracoronary imaging

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6221 Hospitals & Health Systems
Activity scope
Clinical trial registration Cardiac imaging research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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