NCT07566091

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,034

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
24mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Coronary Artery Disease

Keywords

acute coronary syndromechronic coronary syndromeD+Storm Novonixsirolimus-ascorbic acid eluting stenteverolimus-eluting stentpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • The event rate of Target Lesion Failure

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

    1 year

Secondary Outcomes (21)

  • 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

  • +16 more secondary outcomes

Other Outcomes (4)

  • The event rate of Definite or probable stent thrombosis

    1 year

  • The event rate of Definite stent thrombosis

    1 year

  • The event rate of Probable stent thrombosis

    1 year

  • +1 more other outcomes

Study Arms (2)

Sirolimus-Ascorbic Acid Eluting Stent

EXPERIMENTAL

D+STORM NOVONIX stent

Device: Sirolimus-Ascorbic Acid Eluting Stent

Everolimus-Eluting Stent

ACTIVE COMPARATOR

SYNERGY XD

Device: Everolimus-Eluting Stent

Interventions

Everolimus-Eluting StentDEVICE

bioabsorbable polymer everolimus-eluting stent

Everolimus-Eluting Stent
Sirolimus-Ascorbic Acid Eluting StentDEVICE

bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent

Sirolimus-Ascorbic Acid Eluting Stent

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jung-hee Ham Project Manager, Registered Nurse

CONTACT

82-2-3010-4728cvcrc5@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in Department of Cardiology, Asan Medical Center

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

KR(1)