Investigating the safety and performance of bioabsorbable scaffolds for coronary artery disease
Official title: Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
Run by University Hospital of Ferrara · NCT03327961 · Data updated 2026-11-12
This study is testing if bioabsorbable scaffolds can safely help people with coronary artery disease over a year.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1111 (estimated) |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 17 sites (Agrigento, Agrigento and 16 other locations) |
| Status | Recruiting |
| Started | December 2, 2017 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2034 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT03327961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients over 18 years old with coronary artery disease who require scaffold implantation and can commit to a one-year follow-up.
✕Probably not a fit
Patients who cannot guarantee compliance with dual antiplatelet therapy or follow-up for at least one year will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the clinical performance and long-term safety of bioabsorbable scaffold implantation in patients with coronary artery disease across various cath-labs in the Emilia-Romagna region and the MAGIC network. The study will enroll patients who meet specific criteria, including age and lesion characteristics, and will follow a standardized implantation strategy. Data will be collected to assess outcomes and safety over a one-year follow-up period.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative to traditional metallic stents, reducing complications such as thrombosis and restenosis.
How similar studies have gone: Previous studies have shown promise in the use of bioabsorbable scaffolds, but this specific approach in a real-world setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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AO San Giovanni di Dio
Agrigento, Agrigento, Italy Recruiting -
Ospedale Caravaggio-Treviglio
Treviglio, Bergamo, Italy Recruiting -
Azienda Ospedaliera Universitaria di Bologna
Bologna, Bologna, Italy Recruiting -
U.O. Cardiologia, Ospedale Maggiore
Bologna, Bologna, Italy Recruiting -
Ospedale SS Annunziata
Savigliano, Cuneo, Italy Recruiting -
University Hospital of Ferrara
Cona, Ferrara, Italy Recruiting
Show 11 more locations
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U.O. Cardiologia, Ospedale Morgagni Pierantoni
Forlì, Forlì-Cesena, Italy Recruiting -
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
Modena, Modena, Italy Recruiting -
U.O. Cardiologia, Ospedale di Baggiovara
Modena, Modena, Italy Recruiting -
U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
Parma, Parma, Italy Recruiting -
Ospedale Guglielmo da Saliceto
Piacenza, Piacenza, Italy Recruiting -
Maria Cecilia Hospital - GVM Care & Research
Cotignola, Ravenna, Italy Recruiting -
U.O. di Cardiologia, Ospedale Santa Maria delle Croci
Ravenna, Ravenna, Italy Recruiting -
U.O. di Cardiologia, Ospedale degli Infermi
Rimini, Rimini, Italy Recruiting -
AOU San Luigi Gonzaga
Orbassano, Torino, Italy Recruiting -
Ospedale di Rivoli
Rivoli, Torino, Italy Recruiting -
Ospedale di Sanremo
Sanremo, Italy Recruiting
Study contacts
- Study coordinator: Veronica Lodolini
- Email: ldlvnc@unife.it
- Phone: 0532236450
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.