NCT03651180

Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts

Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts: a Cross-sectional Multicentre Consecutive Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,400 (actual)
• Sponsor: Ospedale S. Giovanni Bosco · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.

Detailed description

Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Conditions

• Coronary Artery Disease
• Diabetes Mellitus

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-10-01
• Completion: 2023-10-01
• First posted: 2018-08-29
• Last updated: 2018-08-29

Locations

1 site across 1 country: Italy