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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.
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:
The investigators agreed in the following strategy implantation:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scaffold | Patients receiving during PCI the implantation of at least one scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scaffold | Device | implantation of scaffold (eg Magmaris, Desolve, Others) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Oriented Cardiac Events | cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica Lodolini | Contact | 0532236450 | +39 | ldlvnc@unife.it |
| Elisa Mosele | Contact | 0532236450 | +39 | elisa21mosele@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO San Giovanni di Dio | Recruiting | Agrigento | Agrigento | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Ospedale Caravaggio-Treviglio | Recruiting | Treviglio | Bergamo | Italy |
|
| Azienda Ospedaliera Universitaria di Bologna | Recruiting | Bologna | Bologna | Italy |
|
| U.O. Cardiologia, Ospedale Maggiore | Recruiting | Bologna | Bologna | Italy |
|
| Ospedale SS Annunziata | Recruiting | Savigliano | Cuneo | Italy |
|
| University Hospital of Ferrara | Recruiting | Cona | Ferrara | 44124 | Italy |
|
| U.O. Cardiologia, Ospedale Morgagni Pierantoni | Recruiting | Forlì | Forlì-Cesena | Italy |
|
| U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico | Recruiting | Modena | Modena | Italy |
|
| U.O. Cardiologia, Ospedale di Baggiovara | Recruiting | Modena | Modena | Italy |
|
| U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma | Recruiting | Parma | Parma | Italy |
|
| Ospedale Guglielmo da Saliceto | Recruiting | Piacenza | Piacenza | Italy |
|
| Maria Cecilia Hospital - GVM Care & Research | Recruiting | Cotignola | Ravenna | Italy |
|
| U.O. di Cardiologia, Ospedale Santa Maria delle Croci | Recruiting | Ravenna | Ravenna | Italy |
|
| U.O. di Cardiologia, Ospedale degli Infermi | Recruiting | Rimini | Rimini | Italy |
|
| AOU San Luigi Gonzaga | Recruiting | Orbassano | Torino | Italy |
|
| Ospedale di Rivoli | Recruiting | Rivoli | Torino | Italy |
|
| Ospedale di Sanremo | Recruiting | Sanremo | Italy |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |