An interventional study of Orsiro and Synergy in Acute Coronary Syndrome, Angina Pectoris and Angina, Unstable, sponsored by Foundation of Cardiovascular Research and Education Enschede. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Foundation of Cardiovascular Research and Education Enschede · Not applicable, Interventional, and Treatment
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 3,514 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Foundation of Cardiovascular Research and Education Enschede is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Orsiro
Device: Synergy
Device: Resolute Integrity
biodegradable polymer sirolimus eluting stent
biodegradable polymer everolimus eluting stent
durable polymer zotarolimus-eluting stent
Target vessel failure (TVF)
Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.
Time frame: 1 year
Target lesion failure (TLF)
Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization
Time frame: 1 year
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Foundation of Cardiovascular Research and Education Enschede