Asan Medical Center
Seoul, South Korea
Location contact
Jung-min Ahn, MD
CONTACT
Jung-min Ahn, MD, PhD
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07566091
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Sirolimus-Ascorbic Acid Eluting Stent
Devicebioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
everolimus-eluting stent
Devicebioabsorbable polymer everolimus-eluting stent
Primary outcomes
-
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.
Secondary outcomes
-
The event rate of Device success
Time frame: 1 year
Acute Success Endpoints_lesion level
-
The event rate of Procedural success
Time frame: 1 year
Acute Success Endpoints_patient level
-
The event rate of Death from any causes
Time frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
-
The event rate of Any stroke
Time frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
-
The event rate of Any myocardial infarction
Time frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
-
The event rate of Any repeat revascularization
Time frame: 1 year
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE
-
The event rate of Cardiovascular death
Time frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
-
The event rate of Target vessel myocardial infarction
Time frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
-
The event rate of Target vessel revascularization
Time frame: 1 year
Major Composite Clinical Endpoints_Target Vessel Failure
-
The event rate of All-cause death
Time frame: 1 year
Individual Clinical Endpoints_Mortality
-
The event rate of Cardiac death
Time frame: 1 year
Individual Clinical Endpoints_Mortality
-
The event rate of Non-cardiac death
Time frame: 1 year
Individual Clinical Endpoints_Mortality
-
The event rate of All myocardial infarction including Q wave and Non-Q wave
Time frame: 1 year
Individual Clinical Endpoints_Myocardial Infarction
-
The event rate of Non-target vessel myocardial infarction
Time frame: 1 year
Individual Clinical Endpoints_Myocardial Infarction
-
The event rate of All revascularization
Time frame: 1 year
Individual Clinical Endpoints_Revascularization
-
The event rate of All target lesion revascularization
Time frame: 1 year
Individual Clinical Endpoints_Revascularization
-
The event rate of All target vessel revascularization
Time frame: 1 year
Individual Clinical Endpoints_Revascularization
-
The event rate of Non-target vessel revascularization
Time frame: 1 year
Individual Clinical Endpoints_Revascularization
-
The event rate of Any stroke
Time frame: 1 year
Individual Clinical Endpoints_Stroke
-
The event rate of Ischemic stroke
Time frame: 1 year
Individual Clinical Endpoints_Stroke
-
The event rate of Hemorrhagic stroke
Time frame: 1 year
Individual Clinical Endpoints_Stroke
Other outcomes
-
The event rate of Definite or probable stent thrombosis
Time frame: 1 year
Safety Endpoints
-
The event rate of Definite stent thrombosis
Time frame: 1 year
Safety Endpoints
-
The event rate of Probable stent thrombosis
Time frame: 1 year
Safety Endpoints
-
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
Time frame: 1 year
Safety Endpoints
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Jung-min Ahn
Other
Collaborators
- The CardioVascular Research Foundation (CVRF)
Registry information
Acronym: NOVA
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- May 4, 2026
- Registry last updated
- May 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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