Clinical trial NCT03327961: Scaffold in Emilia Romagna and in the MAGIC Network
Official title: Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 1111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

Brief 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.

Detailed description: Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.

The aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.

The investigators agreed in the following preferential/optimal indications:

* complete revascularization in patients with age \<65 years
* revascularization of long lesions (\>24 mm), especially located in left anterior descending
* spontaneous coronary dissection

The investigators agreed in the following strategy implantation:

* mandatory predilatation
* sizing 1:1
* to avoid vessel with reference vessel diameter \<2.8 mm and \>3.8 mm
* to avoid vessel with severe calcifications
* mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter

The study organization is based on:

DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.

CORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria

Eligibility criteria: 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 outcomes:
measure: Device Oriented Cardiac Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Treviglio
country: Italy
facility: Ospedale Caravaggio-Treviglio
state: Bergamo
city: Savigliano
country: Italy
facility: Ospedale SS Annunziata
state: Cuneo
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
city: Forlì
country: Italy
facility: U.O. Cardiologia, Ospedale Morgagni Pierantoni
state: Forlì-Cesena
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital - GVM Care & Research
state: Ravenna
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: Torino
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
state: Torino
city: Agrigento
country: Italy
facility: AO San Giovanni di Dio
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria di Bologna
city: Bologna
country: Italy
facility: U.O. Cardiologia, Ospedale Maggiore
city: Modena
country: Italy
facility: U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
city: Modena
country: Italy
facility: U.O. Cardiologia, Ospedale di Baggiovara
city: Parma
country: Italy
facility: U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Ravenna
country: Italy
facility: U.O. di Cardiologia, Ospedale Santa Maria delle Croci
city: Rimini
country: Italy
facility: U.O. di Cardiologia, Ospedale degli Infermi
city: San Remo
country: Italy
facility: Ospedale di Sanremo
Study officials:
References: