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Not yet recruiting NCT07566091

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

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sirolimus-Ascorbic Acid Eluting Stent, Everolimus-Eluting Stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Sirolimus-Ascorbic Acid Eluting Stent
    bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
  • Device Everolimus-Eluting Stent
    bioabsorbable polymer everolimus-eluting stent

Primary outcome measures

  • The event rate of Target Lesion Failure [Time frame: 1 year]
Secondary outcome measures (12)
  • The event rate of Device success [Time frame: 1 year]
  • The event rate of Procedural success [Time frame: 1 year]
  • The event rate of Death from any causes [Time frame: 1 year]
  • The event rate of Any stroke [Time frame: 1 year]
  • The event rate of Any myocardial infarction [Time frame: 1 year]
  • The event rate of Any repeat revascularization [Time frame: 1 year]
  • The event rate of Cardiovascular death [Time frame: 1 year]
  • The event rate of Target vessel myocardial infarction [Time frame: 1 year]
  • The event rate of Target vessel revascularization [Time frame: 1 year]
  • The event rate of All-cause death [Time frame: 1 year]
  • The event rate of Cardiac death [Time frame: 1 year]
  • The event rate of Non-cardiac death [Time frame: 1 year]

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT07566091 · AMCCV 2026-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗