NCT07917234 Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
| NCT ID | NCT07917234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro Cardiologico Monzino |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MAGIC trial is an investigator-initiated, multicenter, randomized (1:1) interventional study designed to evaluate whether drug-coated balloon (DCB) angioplasty guided by computational μFR assessment is superior to conventional angiographic-guided DCB angioplasty in terms of acute physiological outcomes. The study will enroll approximately 250 patients with de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.0-4.0 mm. Participants will be randomized to one of two treatment strategies. In the angiography-guided control group, DCB angioplasty will be performed according to conventional angiographic criteria for an optimal procedural result, including TIMI grade 3 flow, residual stenosis of less than 30%, and absence of coronary artery dissections of type C or greater. In the μFR-guided group, computational μFR will be assessed at baseline, after lesion predilation, and after DCB treatment. Virtual percutaneous coronary intervention (PCI) will be recommended to guide and optimize the angioplasty strategy, with the aim of achieving a final μFR value ≥0.86. If the physiological result remains suboptimal (μFR \<0.86) despite further lesion preparation, a hybrid strategy involving implantation of a drug-eluting stent (DES) will be permitted. The primary endpoint is the proportion of target vessels with a post-procedure μFR value ≥0.86, as assessed by an independent, blinded core laboratory through analysis of final coronary angiograms. Clinical follow-up will be conducted exclusively by telephone over a total period of 24 months.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Patients with a clinical indication to PCI, either for stable coronary artery disease or acute coronary syndromes * Presence of a de novo lesion in a native coronary artery with a reference vessel diameter \>2.0 mm and ≤4.0 mm by visual estimation * Lesion length up to 60 mm * Written informed consent for study participation Exclusion Criteria: * Recent ST-elevation myocardial infarction (within 48 hours) * Presence of visible thrombus at the target lesion site * Participation in another investigational clinical trial * Women who are pregnant or breastfeeding * Severe renal impairment, defined as creatinine clearance or eGFR \<30 ml/min * Left ventricular ejection fraction \<30% * Estimated life expectancy \<12 months * Culprit lesion with stenosis \>99% and/or TIMI flow \<2 * Target lesion not pre-dilated or with unsuccessful pre-dilatation (residual stenosis \>30%) * Marked vessel tortuosity preventing device delivery (per investigator's judgment) * Prior stent implantation in the target segment * Bifurcation lesion where side branch treatment is anticipated * Left main stenosis \>50% or target lesion located in the left main * Target lesion within a saphenous vein graft
Contact & Investigator
Stefano Galli, Cardiologist, MD
PRINCIPAL INVESTIGATOR
Centro Cardiologico Monzino - IRCCS
Frequently Asked Questions
Who can join the NCT07917234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07917234 currently recruiting?
Yes, NCT07917234 is actively recruiting participants. Contact the research team at stefano.galli@cardiologicomonzino.it for enrollment information.
Where is the NCT07917234 trial being conducted?
This trial is being conducted at Cosenza, Italy, Milan, Italy, Verona, Italy, Brescia, Italy.
Who is sponsoring the NCT07917234 clinical trial?
NCT07917234 is sponsored by Centro Cardiologico Monzino. The principal investigator is Stefano Galli, Cardiologist, MD at Centro Cardiologico Monzino - IRCCS. The trial plans to enroll 250 participants.