An observational study in Coronary Artery Disease, sponsored by University Hospital of Ferrara. Recruiting at 17 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Hospital of Ferrara · Observational
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:
The investigators agreed in the following strategy implantation:
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
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 1,111 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
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Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving during PCI the implantation of at least one scaffold
Device: scaffold
implantation of scaffold (eg Magmaris, Desolve, Others)
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
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
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University Hospital of Ferrara →