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

Sponsor
Jung-min Ahn
Study ID
NCT07566091
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
May 4, 2026
Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Jun 15, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
2,034 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sirolimus-Ascorbic Acid Eluting Stent
    D+STORM NOVONIX stent
  • Active Comparator: Everolimus-Eluting Stent
    SYNERGY XD

Primary Outcome Measure

The event rate of Target Lesion Failure [ Time Frame: 1 year ]

Central Contacts

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