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

Study acronym: NOVA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Oct 15, 2026 to Oct 6, 2026 · Site details revised Show 2 more changesShow less
    • Start date changed from estimate of Oct 15, 2026 to Oct 6, 2026
    • Site details revised
  2. Start date: Jun 15, 2026 to Oct 15, 2026 Eligibility criteria expanded, about 47 words · Secondary endpoints: details revised at 21 of 21 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 21 of 21 entries
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07566091
Lead Sponsor Jung-min Ahn
Collaborators: The CardioVascular Research Foundation (CVRF)
Conditions Coronary Artery Disease
Enrollment 2,034 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov