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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jung-hee Ham Project Manager, Registered Nurse
- 전화번호: 82-2-3010-4728
- 이메일: cvcrc5@amc.seoul.kr
연구 장소
-
-
-
Seoul, 대한민국
- 모병
- Asan Medical Center
-
연락하다:
- Jung-min Ahn, MD
- 전화번호: 82-2-3010-4728
- 이메일: cvcrc5@amc.seoul.kr
-
수석 연구원:
- Jung-min Ahn, MD, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
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Cardiogenic shock within 48 hours prior to the procedure
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Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
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Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
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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
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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
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Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
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Patients who are unwilling or unable to comply with the study protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent |
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
활성 비교기: Everolimus-Eluting Stent
SYNERGY XD |
bioabsorbable polymer everolimus-eluting stent |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The event rate of Target Lesion Failure
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The event rate of Device success
기간: 1 year
|
Acute Success Endpoints_lesion level |
1 year
|
|
The event rate of Procedural success
기간: 1 year
|
Acute Success Endpoints_patient level |
1 year
|
|
The event rate of Death from any causes
기간: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any stroke
기간: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any myocardial infarction
기간: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any repeat revascularization
기간: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Cardiovascular death
기간: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel myocardial infarction
기간: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel revascularization
기간: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of All-cause death
기간: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Cardiac death
기간: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Non-cardiac death
기간: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
기간: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of Non-target vessel myocardial infarction
기간: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of All revascularization
기간: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target lesion revascularization
기간: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target vessel revascularization
기간: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Non-target vessel revascularization
기간: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Any stroke
기간: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Ischemic stroke
기간: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Hemorrhagic stroke
기간: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
기간: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Definite stent thrombosis
기간: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Probable stent thrombosis
기간: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
기간: 1 year
|
Safety Endpoints |
1 year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- AMCCV 2026-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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