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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Stefano Galli, Cardiologist, MD
- Telefonnummer: +39 02 5800 2533
- E-Mail: stefano.galli@cardiologicomonzino.it
Studieren Sie die Kontaktsicherung
- Name: Simone Fezzi, Cardiologist, MD, Msc
- Telefonnummer: +39 045 812 2320
- E-Mail: simone.fezzi@aovr.veneto.it
Studienorte
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-
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Brescia, Italien
- Noch keine Rekrutierung
- Fondazione Poliambulanza Istituto Ospedaliero
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Kontakt:
- Diego Maffeo Diego, MD
- E-Mail: diego.maffeo@poliambulanza.it
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CS
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Cosenza, CS, Italien, 87100
- Noch keine Rekrutierung
- Azienda ospedaliera di Cosenza "Annunziata"
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Kontakt:
- Alberto Polimeni, MD, PhD
- E-Mail: alberto.polimeni@unical.it
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MI
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Milan, MI, Italien, 20138
- Rekrutierung
- Centro Cardiologico Monzino - IRCCS
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Kontakt:
- Stefano Galli, MD
- Telefonnummer: +39 02 5800 2533
- E-Mail: stefano.galli@cardiologicomonzino.it
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VR
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Verona, VR, Italien, 37126
- Noch keine Rekrutierung
- AOUI Verona - Borgo Trento
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Kontakt:
- Simone Fezzi, MD, Msc
- Telefonnummer: +39 045 812 2320
- E-Mail: simone.fezzi@aovr.veneto.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of Target Vessels With Post-Procedure μFR ≥0.86
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Stefano Galli, Cardiologist, MD, Centro Cardiologico Monzino - IRCCS
- Studienstuhl: Simone Fezzi, Cardiologist, MD, Msc, Azienda Ospedaliera Universitaria Integrata di Verona - Borgo Trento
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CCM NP1180
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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