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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Stefano Galli, Cardiologist, MD
- Telefoonnummer: +39 02 5800 2533
- E-mail: stefano.galli@cardiologicomonzino.it
Studie Contact Back-up
- Naam: Simone Fezzi, Cardiologist, MD, Msc
- Telefoonnummer: +39 045 812 2320
- E-mail: simone.fezzi@aovr.veneto.it
Studie Locaties
-
-
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Brescia, Italië
- Nog niet aan het werven
- Fondazione Poliambulanza Istituto Ospedaliero
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Contact:
- Diego Maffeo Diego, MD
- E-mail: diego.maffeo@poliambulanza.it
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CS
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Cosenza, CS, Italië, 87100
- Nog niet aan het werven
- Azienda ospedaliera di Cosenza "Annunziata"
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Contact:
- Alberto Polimeni, MD, PhD
- E-mail: alberto.polimeni@unical.it
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MI
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Milan, MI, Italië, 20138
- Werving
- Centro Cardiologico Monzino - IRCCS
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Contact:
- Stefano Galli, MD
- Telefoonnummer: +39 02 5800 2533
- E-mail: stefano.galli@cardiologicomonzino.it
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-
VR
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Verona, VR, Italië, 37126
- Nog niet aan het werven
- AOUI Verona - Borgo Trento
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Contact:
- Simone Fezzi, MD, Msc
- Telefoonnummer: +39 045 812 2320
- E-mail: simone.fezzi@aovr.veneto.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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. |
|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of Target Vessels With Post-Procedure μFR ≥0.86
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Stefano Galli, Cardiologist, MD, Centro Cardiologico Monzino - IRCCS
- Studie stoel: Simone Fezzi, Cardiologist, MD, Msc, Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
Studie record data
Bestudeer belangrijke data
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Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CCM NP1180
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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