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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Sirolimus-Ascorbic Acid Eluting Stent; Device: Everolimus-Eluting Stent

• Study Type: Interventional
• Enrollment (Estimated): 2034
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-hee Ham Project Manager, Registered Nurse; Phone Number: 82-2-3010-4728; Email: cvcrc5@amc.seoul.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Asan Medical Center
    • Contact: Jung-min Ahn, MD; Phone Number: 82-2-3010-4728; Email: cvcrc5@amc.seoul.kr
    • Principal Investigator: Jung-min Ahn, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult men and women aged 19 years or older
2. Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
3. Patients who have voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

1. Cardiogenic shock within 48 hours prior to the procedure
2. Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
3. Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
4. Women who are pregnant, breastfeeding, or of childbearing potential
5. 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
6. Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
7. Patients who are unwilling or unable to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus-Ascorbic Acid Eluting Stent; D+STORM NOVONIX stent	Device: Sirolimus-Ascorbic Acid Eluting Stent; bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
Active Comparator: Everolimus-Eluting Stent; SYNERGY XD	Device: Everolimus-Eluting Stent; bioabsorbable polymer everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of Device success	Acute Success Endpoints_lesion level	1 year
The event rate of Procedural success	Acute Success Endpoints_patient level	1 year
The event rate of Death from any causes	Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE	1 year
The event rate of Any stroke	Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE	1 year
The event rate of Any myocardial infarction	Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE	1 year
The event rate of Any repeat revascularization	Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE	1 year
The event rate of Cardiovascular death	Major Composite Clinical Endpoints_Target Vessel Failure	1 year
The event rate of Target vessel myocardial infarction	Major Composite Clinical Endpoints_Target Vessel Failure	1 year
The event rate of Target vessel revascularization	Major Composite Clinical Endpoints_Target Vessel Failure	1 year
The event rate of All-cause death	Individual Clinical Endpoints_Mortality	1 year
The event rate of Cardiac death	Individual Clinical Endpoints_Mortality	1 year
The event rate of Non-cardiac death	Individual Clinical Endpoints_Mortality	1 year
The event rate of All myocardial infarction including Q wave and Non-Q wave	Individual Clinical Endpoints_Myocardial Infarction	1 year
The event rate of Non-target vessel myocardial infarction	Individual Clinical Endpoints_Myocardial Infarction	1 year
The event rate of All revascularization	Individual Clinical Endpoints_Revascularization	1 year
The event rate of All target lesion revascularization	Individual Clinical Endpoints_Revascularization	1 year
The event rate of All target vessel revascularization	Individual Clinical Endpoints_Revascularization	1 year
The event rate of Non-target vessel revascularization	Individual Clinical Endpoints_Revascularization	1 year
The event rate of Any stroke	Individual Clinical Endpoints_Stroke	1 year
The event rate of Ischemic stroke	Individual Clinical Endpoints_Stroke	1 year
The event rate of Hemorrhagic stroke	Individual Clinical Endpoints_Stroke	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of Definite or probable stent thrombosis	Safety Endpoints	1 year
The event rate of Definite stent thrombosis	Safety Endpoints	1 year
The event rate of Probable stent thrombosis	Safety Endpoints	1 year
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5	Safety Endpoints	1 year

Collaborators and Investigators

• Sponsor: Jung-min Ahn
• Collaborators: The CardioVascular Research Foundation (CVRF)

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; acute coronary syndrome; everolimus-eluting stent; chronic coronary syndrome; D+Storm Novonix; sirolimus-ascorbic acid eluting stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Acute Coronary Syndrome
• Other Study ID Numbers: AMCCV 2026-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No