Scaffold in Emilia Romagna and in the MAGIC Network

NCT03327961 · tracked via the Priya Life Science Italy tracker

Sponsor

University Hospital of Ferrara

Phase

Observational

Started

2017-12-02

Last updated

2026-05-01

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

scaffold

scaffold: implantation of scaffold (eg Magmaris, Desolve, Others)

Study summary

The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * subjects \>18 years * sign of the patients informed consent * implanation of at least one scaffold Exclusion Criteria: * inability to garantuee at least one year follow-up * inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen

Primary outcome measure(s)

Device Oriented Cardiac Events — 1 year
cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold

Trial sites (17)

Facility	City	Region	Status
AO San Giovanni di Dio	Agrigento	Agrigento	Recruiting
Ospedale Caravaggio-Treviglio	Treviglio	Bergamo	Recruiting
Azienda Ospedaliera Universitaria di Bologna	Bologna	Bologna	Recruiting
U.O. Cardiologia, Ospedale Maggiore	Bologna	Bologna	Recruiting
Ospedale SS Annunziata	Savigliano	Cuneo	Recruiting
University Hospital of Ferrara	Cona	Ferrara	Recruiting
U.O. Cardiologia, Ospedale Morgagni Pierantoni	Forlì	Forlì-Cesena	Recruiting
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico	Modena	Modena	Recruiting
U.O. Cardiologia, Ospedale di Baggiovara	Modena	Modena	Recruiting
U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma	Parma	Parma	Recruiting
Ospedale Guglielmo da Saliceto	Piacenza	Piacenza	Recruiting
Maria Cecilia Hospital - GVM Care & Research	Cotignola	Ravenna	Recruiting
U.O. di Cardiologia, Ospedale Santa Maria delle Croci	Ravenna	Ravenna	Recruiting
U.O. di Cardiologia, Ospedale degli Infermi	Rimini	Rimini	Recruiting
AOU San Luigi Gonzaga	Orbassano	Torino	Recruiting
Ospedale di Rivoli	Rivoli	Torino	Recruiting
Ospedale di Sanremo	Sanremo	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03327961 on ClinicalTrials.gov ↗ ← All trials in Italy