Scaffold in Emilia Romagna and in the MAGIC Network
- Conditions
- Coronary Artery Disease
- Interventions
- Device: scaffold
- Registration Number
- NCT03327961
- Lead Sponsor
- University Hospital of Ferrara
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1111
- subjects >18 years
- sign of the patients informed consent
- implanation of at least one scaffold
- inability to garantuee at least one year follow-up
- inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description scaffold scaffold Patients receiving during PCI the implantation of at least one scaffold
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Maria Cecilia Hospital - GVM Care & Research
🇮🇹Cotignola, Ravenna, Italy
Ospedale Caravaggio-Treviglio
🇮🇹Treviglio, Bergamo, Italy
Ospedale SS Annunziata
🇮🇹Savigliano, Cuneo, Italy
University Hospital of Ferrara
🇮🇹Cona, Ferrara, Italy
U.O. Cardiologia, Ospedale Morgagni Pierantoni
🇮🇹Forlì, Forlì-Cesena, Italy
AOU San Luigi Gonzaga
🇮🇹Orbassano, Torino, Italy
Ospedale di Rivoli
🇮🇹Rivoli, Torino, Italy
AO San Giovanni di Dio
🇮🇹Agrigento, Italy
Azienda Ospedaliera Universitaria di Bologna
🇮🇹Bologna, Italy
U.O. Cardiologia, Ospedale Maggiore
🇮🇹Bologna, Italy
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
🇮🇹Modena, Italy
U.O. Cardiologia, Ospedale di Baggiovara
🇮🇹Modena, Italy
U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
U.O. di Cardiologia, Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
U.O. di Cardiologia, Ospedale degli Infermi
🇮🇹Rimini, Italy
Ospedale di Sanremo
🇮🇹San Remo, Italy