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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jung-hee Ham Project Manager, Registered Nurse
- Telefonnummer: 82-2-3010-4728
- E-Mail: cvcrc5@amc.seoul.kr
Studienorte
-
-
-
Seoul, Südkorea
- Rekrutierung
- Asan Medical Center
-
Kontakt:
- Jung-min Ahn, MD
- Telefonnummer: 82-2-3010-4728
- E-Mail: cvcrc5@amc.seoul.kr
-
Hauptermittler:
- Jung-min Ahn, MD, PhD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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 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
-
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent |
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
Aktiver Komparator: Everolimus-Eluting Stent
SYNERGY XD |
bioabsorbable polymer everolimus-eluting stent |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The event rate of Target Lesion Failure
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The event rate of Device success
Zeitfenster: 1 year
|
Acute Success Endpoints_lesion level |
1 year
|
|
The event rate of Procedural success
Zeitfenster: 1 year
|
Acute Success Endpoints_patient level |
1 year
|
|
The event rate of Death from any causes
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any stroke
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any myocardial infarction
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any repeat revascularization
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Cardiovascular death
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel myocardial infarction
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel revascularization
Zeitfenster: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of All-cause death
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Cardiac death
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Non-cardiac death
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of Non-target vessel myocardial infarction
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of All revascularization
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target lesion revascularization
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target vessel revascularization
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Non-target vessel revascularization
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Any stroke
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Ischemic stroke
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Hemorrhagic stroke
Zeitfenster: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
Zeitfenster: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Definite stent thrombosis
Zeitfenster: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Probable stent thrombosis
Zeitfenster: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
Zeitfenster: 1 year
|
Safety Endpoints |
1 year
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AMCCV 2026-02
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .