Coronary Artery DiseaseNOVANCT07566091
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
A study testing Sirolimus-Ascorbic Acid Eluting Stent and Everolimus-Eluting Stent in people with Coronary Artery Disease, run by Jung-min Ahn at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sirolimus-Ascorbic Acid Eluting Stent and Everolimus-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,034 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2026to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 who meet any of the following:
- Have not confirmed a negative pregnancy test prior to enrollment
- Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jung-min Ahn, MD, 82-2-3010-4728, cvcrc5@amc.seoul.kr
Jung-min Ahn, MD, PhD
About this study
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
- Coronary Artery Disease
- Being tested
- Sirolimus-Ascorbic Acid Eluting Stent, Everolimus-Eluting Stent
- Keywords
- acute coronary syndrome, chronic coronary syndrome, D+Storm Novonix, sirolimus-ascorbic acid eluting stent, everolimus-eluting stent, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-Ascorbic Acid Eluting StentDevice
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
Everolimus-Eluting StentDevice
bioabsorbable polymer everolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus-Ascorbic Acid Eluting Stent | Experimental | D+STORM NOVONIX stent Receives: Device: Sirolimus-Ascorbic Acid Eluting Stent |
| Everolimus-Eluting Stent | Active comparator | SYNERGY XD Receives: Device: Everolimus-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (21)
The event rate of Device success
Acute Success Endpoints_lesion level
Measured: 1 year
The event rate of Procedural success
Acute Success Endpoints_patient level
Measured: 1 year
The event rate of Death from any causes
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
Measured: 1 year
The event rate of Any stroke
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
Measured: 1 year
The event rate of Any myocardial infarction
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
Measured: 1 year
The event rate of Any repeat revascularization
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
Measured: 1 year
The event rate of Cardiovascular death
Major Composite Clinical Endpoints_Target Vessel Failure
Measured: 1 year
The event rate of Target vessel myocardial infarction
Major Composite Clinical Endpoints_Target Vessel Failure
Measured: 1 year
The event rate of Target vessel revascularization
Major Composite Clinical Endpoints_Target Vessel Failure
Measured: 1 year
The event rate of All-cause death
Individual Clinical Endpoints_Mortality
Measured: 1 year
The event rate of Cardiac death
Individual Clinical Endpoints_Mortality
Measured: 1 year
The event rate of Non-cardiac death
Individual Clinical Endpoints_Mortality
Measured: 1 year
The event rate of All myocardial infarction including Q wave and Non-Q wave
Individual Clinical Endpoints_Myocardial Infarction
Measured: 1 year
The event rate of Non-target vessel myocardial infarction
Individual Clinical Endpoints_Myocardial Infarction
Measured: 1 year
The event rate of All revascularization
Individual Clinical Endpoints_Revascularization
Measured: 1 year
The event rate of All target lesion revascularization
Individual Clinical Endpoints_Revascularization
Measured: 1 year
The event rate of All target vessel revascularization
Individual Clinical Endpoints_Revascularization
Measured: 1 year
The event rate of Non-target vessel revascularization
Individual Clinical Endpoints_Revascularization
Measured: 1 year
The event rate of Any stroke
Individual Clinical Endpoints_Stroke
Measured: 1 year
The event rate of Ischemic stroke
Individual Clinical Endpoints_Stroke
Measured: 1 year
The event rate of Hemorrhagic stroke
Individual Clinical Endpoints_Stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start6 Oct 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,034 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jung-min Ahn
- Sponsor type
- University, hospital or other
- Collaborators
- The CardioVascular Research Foundation (CVRF)
- Responsible party
- Sponsor-investigator, Jung-min Ahn, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566091
- Sponsor's protocol ID
- AMCCV 2026-02
- Acronym
- NOVA
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
- ClinicalTrials.gov ID
- NCT07566091
- Acronym / sponsor ID
- NOVA / AMCCV 2026-02
- Conditions
- Coronary Artery Disease
- Keywords
- acute coronary syndrome, chronic coronary syndrome, D+Storm Novonix, sirolimus-ascorbic acid eluting stent, everolimus-eluting stent, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,034 participants (estimated)
- Lead sponsor
- Jung-min AhnUniversity, hospital or other
- Collaborators
- The CardioVascular Research Foundation (CVRF)
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus-Ascorbic Acid Eluting Stent | Experimental | Device: Sirolimus-Ascorbic Acid Eluting StentD+STORM NOVONIX stent |
| Everolimus-Eluting Stent | Active comparator | Device: Everolimus-Eluting StentSYNERGY XD |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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 who meet any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus-Ascorbic Acid Eluting Stentbioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent | Device | Sirolimus-Ascorbic Acid Eluting Stent |
| Everolimus-Eluting Stentbioabsorbable polymer everolimus-eluting stent | Device | Everolimus-Eluting Stent |
Primary outcome
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.
21 secondary outcomes
The event rate of Device success
Time frame: 1 year
The event rate of Procedural success
Time frame: 1 year
The event rate of Death from any causes
Time frame: 1 year
The event rate of Any stroke
Time frame: 1 year
The event rate of Any myocardial infarction
Time frame: 1 year
The event rate of Any repeat revascularization
Time frame: 1 year
The event rate of Cardiovascular death
Time frame: 1 year
The event rate of Target vessel myocardial infarction
Time frame: 1 year
The event rate of Target vessel revascularization
Time frame: 1 year
The event rate of All-cause death
Time frame: 1 year
The event rate of Cardiac death
Time frame: 1 year
The event rate of Non-cardiac death
Time frame: 1 year
The event rate of All myocardial infarction including Q wave and Non-Q wave
Time frame: 1 year
The event rate of Non-target vessel myocardial infarction
Time frame: 1 year
The event rate of All revascularization
Time frame: 1 year
The event rate of All target lesion revascularization
Time frame: 1 year
The event rate of All target vessel revascularization
Time frame: 1 year
The event rate of Non-target vessel revascularization
Time frame: 1 year
The event rate of Any stroke
Time frame: 1 year
The event rate of Ischemic stroke
Time frame: 1 year
The event rate of Hemorrhagic stroke
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus-Ascorbic Acid Eluting Stent and Everolimus-Eluting Stent in people with Coronary Artery Disease, run by Jung-min Ahn at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-hee Ham Project Manager, Registered Nurse (82-2-3010-4728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The event rate of Target Lesion Failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.