ClinicalTrials.gg
RecruitingNCT07566091NOVAUpdated Oct 7, 2026

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

An interventional study of Sirolimus-Ascorbic Acid Eluting Stent and Everolimus-Eluting Stent in Coronary Artery Disease, sponsored by Jung-min Ahn. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Jung-min Ahn · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 7, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
2,034
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 361 studies in Coronary Artery Disease with a site in Korea, Republic of — 81 open to participants now, 103 under way, 2 of them phase 3. Coronary Artery Disease · Korea, Republic of.

Planned enrollment
42nd of 208
2,034 · median 472
Started
2026
with 12 others
No phase
91 of 361
32 open now
Primary completion
2027-06
later than 43 of 102 live
Registered
356th of 361
by date

Among the 361 studies in Coronary Artery Disease with a site in Korea, Republic of, this one is the 42nd largest by planned enrollment of the 208 interventional ones that give a count, is one of 13 that started in 2026, is one of 91 with no phase, reaches primary completion later than 43 of the 102 other live ones, and was the 356th registered.

Coronary Artery Disease

4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

81 of the 361 studies in Coronary Artery Disease with a site in Korea, Republic of are open now. Recruiting first, the newest first:

75 more — sign in →

All 81 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 361 studies in Coronary Artery Disease with a site in Korea, Republic of, or all of them as a file.
02

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.

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • acute coronary syndrome
  • chronic coronary syndrome
  • D+Storm Novonix
  • sirolimus-ascorbic acid eluting stent
  • everolimus-eluting stent
  • percutaneous coronary intervention
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Cardiogenic shock within 48 hours prior to the procedure
  2. Known 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 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 during the study period
  5. abnormalities identified during study visits, physical examination, laboratory tests, or (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
  6. 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
2,034 participants (estimated)

Study arms

  • Experimental
    Sirolimus-Ascorbic Acid Eluting Stent

    D+STORM NOVONIX stent

    Device: Sirolimus-Ascorbic Acid Eluting Stent

  • Active comparator
    Everolimus-Eluting Stent

    SYNERGY XD

    Device: Everolimus-Eluting Stent

Interventions

  • DeviceSirolimus-Ascorbic Acid Eluting Stent

    bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent

  • DeviceEverolimus-Eluting Stent

    bioabsorbable polymer everolimus-eluting stent

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. The event rate of Device success

    Acute Success Endpoints\_lesion level

    Time frame: 1 year

  2. The event rate of Procedural success

    Acute Success Endpoints\_patient level

    Time frame: 1 year

  3. The event rate of Death from any causes

    Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

    Time frame: 1 year

  4. The event rate of Any stroke

    Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

    Time frame: 1 year

  5. The event rate of Any myocardial infarction

    Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

    Time frame: 1 year

  6. The event rate of Any repeat revascularization

    Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE

    Time frame: 1 year

  7. The event rate of Cardiovascular death

    Major Composite Clinical Endpoints\_Target Vessel Failure

    Time frame: 1 year

  8. The event rate of Target vessel myocardial infarction

    Major Composite Clinical Endpoints\_Target Vessel Failure

    Time frame: 1 year

  9. The event rate of Target vessel revascularization

    Major Composite Clinical Endpoints\_Target Vessel Failure

    Time frame: 1 year

  10. The event rate of All-cause death

    Individual Clinical Endpoints\_Mortality

    Time frame: 1 year

  11. The event rate of Cardiac death

    Individual Clinical Endpoints\_Mortality

    Time frame: 1 year

  12. The event rate of Non-cardiac death

    Individual Clinical Endpoints\_Mortality

    Time frame: 1 year

  13. The event rate of All myocardial infarction including Q wave and Non-Q wave

    Individual Clinical Endpoints\_Myocardial Infarction

    Time frame: 1 year

  14. The event rate of Non-target vessel myocardial infarction

    Individual Clinical Endpoints\_Myocardial Infarction

    Time frame: 1 year

  15. The event rate of All revascularization

    Individual Clinical Endpoints\_Revascularization

    Time frame: 1 year

  16. The event rate of All target lesion revascularization

    Individual Clinical Endpoints\_Revascularization

    Time frame: 1 year

  17. The event rate of All target vessel revascularization

    Individual Clinical Endpoints\_Revascularization

    Time frame: 1 year

  18. The event rate of Non-target vessel revascularization

    Individual Clinical Endpoints\_Revascularization

    Time frame: 1 year

  19. The event rate of Any stroke

    Individual Clinical Endpoints\_Stroke

    Time frame: 1 year

  20. The event rate of Ischemic stroke

    Individual Clinical Endpoints\_Stroke

    Time frame: 1 year

  21. The event rate of Hemorrhagic stroke

    Individual Clinical Endpoints\_Stroke

    Time frame: 1 year

Other outcomes

  1. The event rate of Definite or probable stent thrombosis

    Safety Endpoints

    Time frame: 1 year

  2. The event rate of Definite stent thrombosis

    Safety Endpoints

    Time frame: 1 year

  3. The event rate of Probable stent thrombosis

    Safety Endpoints

    Time frame: 1 year

  4. The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5

    Safety Endpoints

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 8 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
May 4, 2026
StartActual
Oct 6, 2026
Primary completionEst.
Jun 15, 2027
CompletionEst.
Jun 15, 2028
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 7, 2026
Sites
Asan Medical Center is now Recruiting
Oct 7, 2026
Start date
Oct 15, 2026→Oct 6, 2026 (actual)
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Not yet recruiting→Recruiting
    Asan Medical Center is now Recruiting
    Start date Oct 15, 2026→Oct 6, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07566091
Lead sponsor
Jung-min Ahn
Collaborators
The CardioVascular Research Foundation (CVRF)
Responsible party
Jung-min Ahn (Professor in Department of Cardiology, Asan Medical Center, Asan Medical Center) — Sponsor-investigator
First posted
May 4, 2026
Start date
Oct 6, 2026
Primary completion
Jun 15, 2027 (estimated)
Completion
Jun 15, 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

Jung-hee Ham Project Manager, Registered Nurse
Contact
cvcrc5@amc.seoul.kr
82-2-3010-4728

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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