Investigating the safety and performance of bioabsorbable scaffolds for coronary artery disease
Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
University Hospital of Ferrara · NCT03327961
This study is testing if bioabsorbable scaffolds can safely help people with coronary artery disease over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Ferrara (other) |
| Locations | 17 sites (Agrigento, Agrigento and 16 other locations) |
| Trial ID | NCT03327961 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promise in the use of bioabsorbable scaffolds, but this specific approach in a real-world setting is relatively novel.
Eligibility criteria
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 this trial is running
Agrigento, Agrigento and 16 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease