NCT07917234Recruiting
Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
Computational μFR-Guided Versus Angiographic Guidance In Drug-Coated Balloon Angioplasty: a Randomized Controlled - Study MAGIC Trial
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Centro Cardiologico Monzino
- Diseases
- Coronary artery disease
- NCT number
- NCT07917234
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 Nov 2026 to the primary completion date, 31 Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior stent implantation in the target segment
Other illness
- Recent ST-elevation myocardial infarction (within 48 hours)
Lab values
- Severe renal impairment, defined as creatinine clearance or eGFR <30 ml/min
- Left ventricular ejection fraction <30%
Other
- Presence of visible thrombus at the target lesion site
- Participation in another investigational clinical trial
- Women who are pregnant or breastfeeding
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Poliambulanza Istituto Ospedaliero Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Azienda ospedaliera di Cosenza "Annunziata" Coordinator of this site? Confirm its status | Cosenza | Italy | Not yet recruiting |
| Centro Cardiologico Monzino IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| AOUI Verona - Borgo Trento Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.