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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: scaffold

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

• Study Type: Observational
• Enrollment (Estimated): 1111

Contacts and Locations

• Study Contact: Name: Veronica Lodolini; Phone Number: +39 0532236450; Email: ldlvnc@unife.it
• Study Contact Backup: Name: Elisa Mosele; Phone Number: +39 0532236450; Email: elisa21mosele@gmail.com

Study Locations

• Italy
  • Agrigento, Italy
    • Recruiting
    • AO San Giovanni di Dio
    • Contact: Salvatore Geraci
  • Bologna, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria di Bologna
    • Contact: Francesco Saia, MD
  • Bologna, Italy
    • Recruiting
    • U.O. Cardiologia, Ospedale Maggiore
    • Contact: Gianni Casella, MD
  • Modena, Italy
    • Recruiting
    • U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
    • Contact: Fabio Sgura
  • Modena, Italy
    • Recruiting
    • U.O. Cardiologia, Ospedale di Baggiovara
    • Contact: Daniele Iaccarino, MD
  • Parma, Italy
    • Recruiting
    • U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
    • Contact: Alberto Menozzi, MD
  • Piacenza, Italy
    • Recruiting
    • Ospedale Guglielmo da Saliceto
    • Contact: Luciano Losi, MD
  • Ravenna, Italy
    • Recruiting
    • U.O. di Cardiologia, Ospedale Santa Maria delle Croci
    • Contact: Marco Balduccelli, MD
  • Rimini, Italy
    • Recruiting
    • U.O. di Cardiologia, Ospedale degli Infermi
    • Contact: Andrea Santarelli, MD
  • San Remo, Italy
    • Recruiting
    • Ospedale di Sanremo
    • Contact: Massimo Leoncini
  • Bergamo
    • Treviglio, Bergamo, Italy
      • Recruiting
      • Ospedale Caravaggio-Treviglio
      • Contact: Paolo Sganzerla
  • Cuneo
    • Savigliano, Cuneo, Italy
      • Recruiting
      • Ospedale SS Annunziata
      • Contact: Baldassarre Doronzo
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Recruiting
      • University Hospital of Ferrara
      • Principal Investigator: Gianluca Campo, MD
      • Sub-Investigator: Carlo Tumscitz, MD
      • Contact: Simone Biscaglia, MD; Phone Number: +390532239883; Email: bscsmn@unife.it
      • Sub-Investigator: Matteo Tebaldi, MD
      • Principal Investigator: Simone Biscaglia, MD
  • Forlì-Cesena
    • Forlì, Forlì-Cesena, Italy
      • Recruiting
      • U.O. Cardiologia, Ospedale Morgagni Pierantoni
      • Contact: Fabio Tarantino, MD
  • Ravenna
    • Cotignola, Ravenna, Italy
      • Recruiting
      • Maria Cecilia Hospital - GVM Care & Research
      • Contact: Paolo Sbarzaglia, MD
  • Torino
    • Orbassano, Torino, Italy
      • Recruiting
      • AOU San Luigi Gonzaga
      • Contact: Enrico Cerrato
    • Rivoli, Torino, Italy
      • Recruiting
      • Ospedale di Rivoli
      • Contact: Fernando Varbella

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
scaffold; Patients receiving during PCI the implantation of at least one scaffold	Device: scaffold; implantation of scaffold (eg Magmaris, Desolve, Others)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 170899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No