Scaffold in Emilia Romagna and in the MAGIC Network

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-02

Study Completion Date

2034-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Gianluca Campo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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Italy

Central Contacts

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Veronica Lodolini

Role: CONTACT

Phone: 0532236450

Review additional registry numbers or institutional identifiers associated with this trial.

170899

Identifier Type: -

Identifier Source: org_study_id

Scaffold in Emilia Romagna and in the MAGIC Network

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

scaffold

scaffold

Interventions

scaffold

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University Hospital of Ferrara

Responsible Party

Gianluca Campo

Locations

AO San Giovanni di Dio

Ospedale Caravaggio-Treviglio

Azienda Ospedaliera Universitaria di Bologna

U.O. Cardiologia, Ospedale Maggiore

Ospedale SS Annunziata

University Hospital of Ferrara

U.O. Cardiologia, Ospedale Morgagni Pierantoni

U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico

U.O. Cardiologia, Ospedale di Baggiovara

U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma

Ospedale Guglielmo da Saliceto

Maria Cecilia Hospital - GVM Care & Research

U.O. di Cardiologia, Ospedale Santa Maria delle Croci

U.O. di Cardiologia, Ospedale degli Infermi

AOU San Luigi Gonzaga

Ospedale di Rivoli

Ospedale di Sanremo

Countries

Central Contacts

Veronica Lodolini

Elisa Mosele

Facility Contacts

Salvatore Geraci

Paolo Sganzerla

Francesco Saia, MD

Gianni Casella, MD

Baldassarre Doronzo

Simone Biscaglia, MD

Gianluca Campo, MD

Matteo Tebaldi, MD

Carlo Tumscitz, MD

Simone Biscaglia, MD

Fabio Tarantino, MD

Fabio Sgura

Daniele Iaccarino, MD

Alberto Menozzi, MD

Luciano Losi, MD

Paolo Sbarzaglia, MD

Marco Balduccelli, MD

Andrea Santarelli, MD

Enrico Cerrato

Fernando Varbella

Massimo Leoncini

Other Identifiers

170899