Scaffold in Emilia Romagna and in the MAGIC Network (SHERPA-MAGIC)

University Hospital of Ferrara

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: scaffold

Study type

Observational

Funder types

Other

Identifiers

NCT03327961

170899

Details and patient eligibility

About

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.

Full 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

Enrollment

1,111 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria