RESOLUTE China Registry: (R-C Registry)
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
調査の概要
詳細な説明
The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.
Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.
1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Beijing、中国、100000
- Beijing Fumwai Hospital
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Beijing、中国、100044
- Peiking University People's Hospital
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Fuzhou、中国、350001
- Fujian Medical University Union Hospital
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Guangdong、中国、510000
- Guangdong Provincial People's Hospital
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Nanjing、中国、210006
- Nanjing First Hospital
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Wuhan、中国、430022
- Wuhan Asia Heart Hospital
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-
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
サンプリング方法
調査対象母集団
Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.
All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.
説明
Inclusion Criteria:
Patient must meet all of the following criteria to be eligible for treatment in the trial:
- Age ≥ 18 years or minimum age as required by local regulations
- The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
- The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
- Intention to electively implant at least one Resolute stent
- The patient is willing and able to cooperate with study procedures and required follow up visits
Exclusion Criteria:
Patients will be excluded from the trial if any of the following criteria are met:
- Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
- Women with known pregnancy or who are lactating
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
- Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
- Previous enrollment in the Resolute China Registry
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
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
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 |
|---|---|---|
|
Target lesion failure (TLF)
時間枠：12m
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Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.
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12m
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall stent thrombosis
時間枠：12m
|
Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
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12m
|
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Device success, Lesion success, Procedural success
時間枠：At the end of the index procedure or during hospital stay
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At the end of the index procedure or during hospital stay
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|
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TLF
時間枠：30 days, 6 months, 2 year, 3 year, 4 year and 5 year
|
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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30 days, 6 months, 2 year, 3 year, 4 year and 5 year
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All deaths (cardiac, vascular and non-cardiovascular)
時間枠：30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
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Stent thrombosis rate
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Myocardial infarction
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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Q wave and non-Q wave MI
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
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Revascularization
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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target lesion and target vessel revascularization (TLR and TVR)
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
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Significant bleeding complications and stroke
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
hemorrhagic in nature
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
|
Target vessel failure (TVF)
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
|
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
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Major adverse cardiac events (MACE)
時間枠：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
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a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods
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at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jiyan Chen, MD、Guangdong Provincial People's Hospital
- 主任研究者：Shubin Qiao, MD、Fu Wai Hospital, Beijing, China
- 主任研究者：Lianglong Chen, MD、Fujian Medical University Union Hospital
- 主任研究者：Shaoliang Chen, MD、The First Affiliated Hospital with Nanjing Medical University
- 主任研究者：Weimin Wang, MD、Peiking University People's Hospital
- 主任研究者：Guoying Zhu, MD、Wuhan Asia Heart Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
- IP124
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