μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study compares two strategies for drug-coated balloon angioplasty in native coronary arteries with 2.0–4.0 mm reference vessels. Participants are assigned 1:1 to μFR-guided planning and assessment or traditional angiography-guided optimization, with μFR measurements taken at baseline, after lesion predilation, and after DCB treatment to guide decisions. The primary goal is to determine if μFR guidance improves acute physiologic outcomes compared with conventional angiographic criteria. Eligible patients include adults with stable CAD or ACS and de novo lesions suitable for DCB, while exclusion criteria include recent STEMI, significant renal impairment, severe LV dysfunction, and other high-risk features. The study is investigator-initiated, conducted at multiple centers, with about 250 participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Cardiologico Monzino - IRCCS
  Milan, Mi, Italy Recruiting
• Azienda ospedaliera di Cosenza "Annunziata"
  Cosenza, Cs, Italy Not yet recruiting
• AOUI Verona - Borgo Trento
  Verona, Vr, Italy Not yet recruiting
• Fondazione Poliambulanza Istituto Ospedaliero
  Brescia, Italy Not yet recruiting

Study contacts

• Principal investigator: Stefano Galli, Cardiologist, MD — Centro Cardiologico Monzino - IRCCS
• Study coordinator: Stefano Galli, Cardiologist, MD
• Email: stefano.galli@cardiologicomonzino.it
• Phone: +39 02 5800 2533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.