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

NCT07566091 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2034

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Sirolimus-Ascorbic Acid Eluting Stent

bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent

DEVICE

Everolimus-Eluting Stent

bioabsorbable polymer everolimus-eluting stent

Sponsors & Collaborators

  • The CardioVascular Research Foundation (CVRF)

    collaborator UNKNOWN

  • Jung-min Ahn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-06-15
Completion
2028-06-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566091 on ClinicalTrials.gov