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Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
Sponsor: Jung-min Ahn
Summary
The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2034
Start Date
2026-10-15
Completion Date
2028-06-15
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Sirolimus-Ascorbic Acid Eluting Stent
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
Everolimus-Eluting Stent
bioabsorbable polymer everolimus-eluting stent
Locations (1)
Asan Medical Center
Seoul, South Korea