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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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
AO San Giovanni di Dio
Agrigento, Agrigento, Italy
Ospedale Caravaggio-Treviglio
Treviglio, Bergamo, Italy
Azienda Ospedaliera Universitaria di Bologna
Bologna, Bologna, Italy
U.O. Cardiologia, Ospedale Maggiore
Bologna, Bologna, Italy
Ospedale SS Annunziata
Savigliano, Cuneo, Italy
University Hospital of Ferrara
Cona, Ferrara, Italy
U.O. Cardiologia, Ospedale Morgagni Pierantoni
Forlì, Forlì-Cesena, Italy
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
Modena, Modena, Italy
U.O. Cardiologia, Ospedale di Baggiovara
Modena, Modena, Italy
U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
Parma, Parma, Italy
Start Date
December 2, 2017
Primary Completion Date
December 31, 2029
Completion Date
December 31, 2034
Last Updated
December 12, 2024
1,111
ESTIMATED participants
scaffold
DEVICE
Lead Sponsor
University Hospital of Ferrara
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323