Coronary Artery DiseaseMAGICNCT07917234
Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
A study testing μFR-Based Group (Intervention) in people with Coronary Artery Disease, run by Centro Cardiologico Monzino at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- μFR-Based Group (Intervention)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Diego Maffeo Diego, MD, diego.maffeo@poliambulanza.it
- Not yet recruiting
Azienda ospedaliera di Cosenza "Annunziata"
Cosenza, CS, 87100
Alberto Polimeni, MD, PhD, alberto.polimeni@unical.it
- Recruiting
Centro Cardiologico Monzino - IRCCS
Milan, MI, 20138
Stefano Galli, MD, +39 02 5800 2533, stefano.galli@cardiologicomonzino.it
- Not yet recruiting
AOUI Verona - Borgo Trento
Verona, VR, 37126
Simone Fezzi, MD, Msc, +39 045 812 2320, simone.fezzi@aovr.veneto.it
About this study
Official title: 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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Being tested
- μFR-Based Group (Intervention)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
μFR-Based Group (Intervention)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Angio-Based Group (Control) | No intervention | 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. |
| μFR-Based Group (Intervention) | Experimental | 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. Receives: Procedure: μFR-Based Group (Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Target Vessels With Post-Procedure μFR ≥0.86
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.
Measured: During procedure
Incidence of Major Clinical Safety Events at 30 Days
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.
Measured: 30 days after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Sponsor
- Investigators
- Stefano Galli, Cardiologist, MD, Principal investigator, Centro Cardiologico Monzino - IRCCSSimone Fezzi, Cardiologist, MD, Msc, Study chair, Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917234
- Sponsor's protocol ID
- CCM NP1180
- Acronym
- MAGIC
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational μFR-Guided Versus Angiographic Guidance In Drug-Coated Balloon Angioplasty: a Randomized Controlled - Study MAGIC Trial
- ClinicalTrials.gov ID
- NCT07917234
- Acronym / sponsor ID
- MAGIC / CCM NP1180
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angio-Based Group (Control) | No intervention | –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. |
| μFR-Based Group (Intervention) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| μFR-Based Group (Intervention)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. | Procedure or surgery | μFR-Based Group (Intervention) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Galli, Cardiologist, MD principal investigator
Centro Cardiologico Monzino - IRCCS
Simone Fezzi, Cardiologist, MD, Msc study chair
Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing μFR-Based Group (Intervention) in people with Coronary Artery Disease, run by Centro Cardiologico Monzino at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Galli, Cardiologist, MD (+39 02 5800 2533, stefano.galli@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Target Vessels With Post-Procedure μFR ≥0.86 (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.