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

April 27, 2026 updated by: Jung-min Ahn
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2034

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Principal Investigator:
          • Jung-min Ahn, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The event rate of Target Lesion Failure
Time Frame: 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The event rate of Device success
Time Frame: 1 year
Acute Success Endpoints_lesion level
1 year
The event rate of Procedural success
Time Frame: 1 year
Acute Success Endpoints_patient level
1 year
The event rate of Death from any causes
Time Frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
1 year
The event rate of Any stroke
Time Frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
1 year
The event rate of Any myocardial infarction
Time Frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
1 year
The event rate of Any repeat revascularization
Time Frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
1 year
The event rate of Cardiovascular death
Time Frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
1 year
The event rate of Target vessel myocardial infarction
Time Frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
1 year
The event rate of Target vessel revascularization
Time Frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
1 year
The event rate of All-cause death
Time Frame: 1 year
Individual Clinical Endpoints_Mortality
1 year
The event rate of Cardiac death
Time Frame: 1 year
Individual Clinical Endpoints_Mortality
1 year
The event rate of Non-cardiac death
Time Frame: 1 year
Individual Clinical Endpoints_Mortality
1 year
The event rate of All myocardial infarction including Q wave and Non-Q wave
Time Frame: 1 year
Individual Clinical Endpoints_Myocardial Infarction
1 year
The event rate of Non-target vessel myocardial infarction
Time Frame: 1 year
Individual Clinical Endpoints_Myocardial Infarction
1 year
The event rate of All revascularization
Time Frame: 1 year
Individual Clinical Endpoints_Revascularization
1 year
The event rate of All target lesion revascularization
Time Frame: 1 year
Individual Clinical Endpoints_Revascularization
1 year
The event rate of All target vessel revascularization
Time Frame: 1 year
Individual Clinical Endpoints_Revascularization
1 year
The event rate of Non-target vessel revascularization
Time Frame: 1 year
Individual Clinical Endpoints_Revascularization
1 year
The event rate of Any stroke
Time Frame: 1 year
Individual Clinical Endpoints_Stroke
1 year
The event rate of Ischemic stroke
Time Frame: 1 year
Individual Clinical Endpoints_Stroke
1 year
The event rate of Hemorrhagic stroke
Time Frame: 1 year
Individual Clinical Endpoints_Stroke
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The event rate of Definite or probable stent thrombosis
Time Frame: 1 year
Safety Endpoints
1 year
The event rate of Definite stent thrombosis
Time Frame: 1 year
Safety Endpoints
1 year
The event rate of Probable stent thrombosis
Time Frame: 1 year
Safety Endpoints
1 year
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
Time Frame: 1 year
Safety Endpoints
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jung-min Ahn

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The CardioVascular Research Foundation (CVRF)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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