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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jung-hee Ham Project Manager, Registered Nurse
- 電話番号：82-2-3010-4728
- メール：cvcrc5@amc.seoul.kr
研究場所
-
-
-
Seoul、韓国
- 募集
- Asan Medical Center
-
コンタクト：
- Jung-min Ahn, MD
- 電話番号：82-2-3010-4728
- メール：cvcrc5@amc.seoul.kr
-
主任研究者：
- Jung-min Ahn, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent |
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
アクティブコンパレータ：Everolimus-Eluting Stent
SYNERGY XD |
bioabsorbable polymer everolimus-eluting stent |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The event rate of Target Lesion Failure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The event rate of Device success
時間枠：1 year
|
Acute Success Endpoints_lesion level |
1 year
|
|
The event rate of Procedural success
時間枠：1 year
|
Acute Success Endpoints_patient level |
1 year
|
|
The event rate of Death from any causes
時間枠：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any stroke
時間枠：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any myocardial infarction
時間枠：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any repeat revascularization
時間枠：1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Cardiovascular death
時間枠：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel myocardial infarction
時間枠：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel revascularization
時間枠：1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of All-cause death
時間枠：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Cardiac death
時間枠：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Non-cardiac death
時間枠：1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
時間枠：1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of Non-target vessel myocardial infarction
時間枠：1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of All revascularization
時間枠：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target lesion revascularization
時間枠：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target vessel revascularization
時間枠：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Non-target vessel revascularization
時間枠：1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Any stroke
時間枠：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Ischemic stroke
時間枠：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Hemorrhagic stroke
時間枠：1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
時間枠：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Definite stent thrombosis
時間枠：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Probable stent thrombosis
時間枠：1 year
|
Safety Endpoints |
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
時間枠：1 year
|
Safety Endpoints |
1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AMCCV 2026-02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。