Scaffold in Emilia Romagna and in the MAGIC Network

Coronary Artery Disease Clinical Trial

— SHERPA-MAGIC  

Official title:

Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327961
• Other study ID #: 170899
• Status: Recruiting
• Start date: December 2, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2023
• Source: University Hospital of Ferrara
• Contact: Veronica Lodolini
• Phone: 0532236450
• Email: ldlvnc[@]unife.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1111
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Italy	AO San Giovanni di Dio	Agrigento
Italy	Azienda Ospedaliera Universitaria di Bologna	Bologna
Italy	U.O. Cardiologia, Ospedale Maggiore	Bologna
Italy	University Hospital of Ferrara	Cona	Ferrara
Italy	Maria Cecilia Hospital - GVM Care & Research	Cotignola	Ravenna
Italy	U.O. Cardiologia, Ospedale Morgagni Pierantoni	Forlì	Forlì-Cesena
Italy	U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico	Modena
Italy	U.O. Cardiologia, Ospedale di Baggiovara	Modena
Italy	AOU San Luigi Gonzaga	Orbassano	Torino
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 Rivoli	Rivoli	Torino
Italy	Ospedale di Sanremo	San Remo
Italy	Ospedale SS Annunziata	Savigliano	Cuneo
Italy	Ospedale Caravaggio-Treviglio	Treviglio	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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