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Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Adult men and women aged 19 years or older

• Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)

• Patients who have voluntarily provided written informed consent to participate in the study

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jung-hee Ham Project Manager, Registered Nurse
cvcrc5@amc.seoul.kr
82-2-3010-4728
Time Frame
Start Date: 2026-10-06
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 2034
Treatments
Experimental: Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent
Active_comparator: Everolimus-Eluting Stent
SYNERGY XD
Sponsors
Collaborators: The CardioVascular Research Foundation (CVRF)
Leads: Jung-min Ahn

This content was sourced from clinicaltrials.gov