Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty (MAGIC)
Computational μFR-Guided Versus Angiographic Guidance In Drug-Coated Balloon Angioplasty: a Randomized Controlled - Study MAGIC Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefano Galli, Cardiologist, MD
- Phone Number: +39 02 5800 2533
- Email: stefano.galli@cardiologicomonzino.it
Study Contact Backup
- Name: Simone Fezzi, Cardiologist, MD, Msc
- Phone Number: +39 045 812 2320
- Email: simone.fezzi@aovr.veneto.it
Study Locations
-
-
-
Brescia, Italy
- Not yet recruiting
- Fondazione Poliambulanza Istituto Ospedaliero
-
Contact:
- Diego Maffeo Diego, MD
- Email: diego.maffeo@poliambulanza.it
-
-
CS
-
Cosenza, CS, Italy, 87100
- Not yet recruiting
- Azienda ospedaliera di Cosenza "Annunziata"
-
Contact:
- Alberto Polimeni, MD, PhD
- Email: alberto.polimeni@unical.it
-
-
MI
-
Milan, MI, Italy, 20138
- Recruiting
- Centro Cardiologico Monzino - IRCCS
-
Contact:
- Stefano Galli, MD
- Phone Number: +39 02 5800 2533
- Email: stefano.galli@cardiologicomonzino.it
-
-
VR
-
Verona, VR, Italy, 37126
- Not yet recruiting
- AOUI Verona - Borgo Trento
-
Contact:
- Simone Fezzi, MD, Msc
- Phone Number: +39 045 812 2320
- Email: simone.fezzi@aovr.veneto.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Angio-Based Group (Control)
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. |
|
|
Experimental: μFR-Based Group (Intervention)
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. |
Drug-coated balloon (DCB) angioplasty guided by computational μFR assessment. μFR is measured at baseline, after lesion predilation, and after DCB treatment. Virtual PCI based on μFR is recommended to guide lesion preparation and optimize the angioplasty strategy, targeting a final μFR value ≥0.86. If μFR remains <0.86 despite further lesion preparation, a hybrid strategy involving drug-eluting stent (DES) implantation is permitted. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Target Vessels With Post-Procedure μFR ≥0.86
Time Frame: During procedure
|
The primary efficacy endpoint is the proportion of target vessels achieving a post-procedure μFR value ≥0.86, as assessed by an independent, blinded core laboratory based on analysis of the final coronary angiograms. |
During procedure
|
|
Incidence of Major Clinical Safety Events at 30 Days
Time Frame: 30 days after the index procedure
|
Incidence of the composite safety endpoint including BARC type 3 or 5 bleeding, definite lesion thrombosis or target-segment occlusion, any stroke, any myocardial infarction, and cardiovascular death. The endpoint will be assessed at 30 days after the index procedure. |
30 days after the index procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stefano Galli, Cardiologist, MD, Centro Cardiologico Monzino - IRCCS
- Study Chair: Simone Fezzi, Cardiologist, MD, Msc, Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCM NP1180
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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