μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
| Registry | NCT07598565 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 350 (Estimated) |
| Sponsor | University of Roma La Sapienza (Other) |
| Conditions | Acute Coronary Syndromes (ACS), NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease |
| Interventions | Angiography-guided PCI, μFR based-PCI (Procedure) |
| Dates | start 2026-05-18 (estimated), primary completion 2027-06-25 (estimated), completion 2028-06-30 (estimated), first posted 2026-05-20, last updated 2026-05-22 |
| Locations | 1 site in Italy |
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All trials for Acute Coronary Syndromes (ACS) All trials for NSTEMI - Non-ST-Segment Elevation Myocardial Infarction All trials of Angiography-guided PCI All trials of μFR based-PCI
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is >0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A - Angiography-guided PCI (standard strategy) | Active comparator | Procedure: Angiography-guided PCI | Patients will undergo a staged PCI of all non-culprit vessels identified before randomization according to angiography and operator judgment, as per standard of care. μFR will be analyzed off-line by the core lab and will not be available to the operator. |
| Group B - μFR based-PCI | Experimental | Procedure: μFR based-PCI | μFR will be analyzed off-line by the core lab. Coronary revascularization will be deferred if the μFR > 0.80 in all the non-culprit vessels identified before randomization. If μFR ≤ 0.80 in at least one non-culprit vessels identified before randomization, patients will undergo a staged PCI. Operators remain blinded to μFR values, and treatment of vessels is based on angiography only. |
Sex: All
Inclusion Criteria: 1. Patients presenting with ACS within 72 hours of successful culprit PCI 2. Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics: 1. at least 50% diameter stenosis by visual assessment 2. a vessel diameter of at least 2.5 mm 3. amenable to successful PCI Exclusion Criteria: 1. Cardiogenic shock or severe heart failure (NYHA class ≥III) 2. Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m² 3. Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated 4. Pregnancy or intention to become pregnant during the trial 5. Life expectancy less than one year 6. Ambiguity in the identification of the culprit vessel/lesion 7. Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome 8. Any ambiguity in the diagnosis of ACS 9. Inability to provide informed consent 10. Patients with only one coronary artery lesion with diameter stenosis >90% and/or TIMI flow <3 11. Patients in whom the NCV is treated at the time of the index procedure 12. An interrogated lesion is at the site of a myocardial bridge 13. An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction 14. An interrogated lesion is in a bypass graft 15. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification 16. Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement
| Facility | City | Country | Status |
|---|---|---|---|
| Azienda ospedaliero - universitaria Sant'Andrea | Roma, RM | Italy |