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Clinical Trials/NCT07566091
NCT07566091Not yet recruitingNot Applicable

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

Jung-min Ahn1 site in 1 country2,034 target enrollmentStarted: October 15, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
2,034
Locations
1
Primary Endpoint
The event rate of Target Lesion Failure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Cardiogenic shock within 48 hours prior to the procedure
  • •Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
  • •Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
  • •Women who are pregnant, breastfeeding, or of childbearing potential who meet any of the following:
  • •Have not confirmed a negative pregnancy test prior to enrollment
  • •Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
  • •Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
  • •Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
  • •Patients who are unwilling or unable to comply with the study protocol

Arms & Interventions

Sirolimus-Ascorbic Acid Eluting Stent

Experimental

D+STORM NOVONIX stent

Intervention: Sirolimus-Ascorbic Acid Eluting Stent (Device)

Everolimus-Eluting Stent

Active Comparator

SYNERGY XD

Intervention: Everolimus-Eluting Stent (Device)

Outcomes

Primary Outcomes

The event rate of Target Lesion Failure

Time Frame: 1 year

Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.

Secondary Outcomes

  • The event rate of Device success(1 year)
  • The event rate of Procedural success(1 year)
  • The event rate of Death from any causes(1 year)
  • The event rate of Any stroke(1 year)
  • The event rate of Any myocardial infarction(1 year)
  • The event rate of Any repeat revascularization(1 year)
  • The event rate of Cardiovascular death(1 year)
  • The event rate of Target vessel myocardial infarction(1 year)
  • The event rate of Target vessel revascularization(1 year)
  • The event rate of All-cause death(1 year)
  • The event rate of Cardiac death(1 year)
  • The event rate of Non-cardiac death(1 year)
  • The event rate of All myocardial infarction including Q wave and Non-Q wave(1 year)
  • The event rate of Non-target vessel myocardial infarction(1 year)
  • The event rate of All revascularization(1 year)
  • The event rate of All target lesion revascularization(1 year)
  • The event rate of All target vessel revascularization(1 year)
  • The event rate of Non-target vessel revascularization(1 year)
  • The event rate of Ischemic stroke(1 year)
  • The event rate of Hemorrhagic stroke(1 year)

Investigators

Sponsor
Jung-min Ahn
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jung-min Ahn

Professor in Department of Cardiology, Asan Medical Center

Asan Medical Center

Study Sites (1)

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