XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-arm Study (XIENCE V India)
XIENCE V® Everolimus Eluting Coronary Stent System India Post-marketing Single-Arm Study
調査の概要
詳細な説明
Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.
Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Single-Arm Study (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval XIENCE V India study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the XIENCE V India study, from 5 years to after completion of the three year follow-up.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ahmedabad、インド、380054
- Sal Hospital and Medical Institute
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Amritsar、インド
- Escorts Heart & Superspeciality Institute Ltd.
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Chennai、インド、600 037
- Madras Medical Mission
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Cochin、インド
- Lisie Heart Institute,Lisie Hosp.
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Hyderabad、インド、500033
- Apollo Hospital
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Jaipur、インド
- Heart & General Hospital
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Mumbai、インド、400050
- Holy Family Hospital
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New Delhi、インド、110025
- Escorts Heart Institute & Research Centre
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New Delhi、インド、110017
- Max Devki Devi Heart & Vascular Institute
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New Delhi、インド、110 070
- Escorts Heart Institute & Research Centre
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New Delhi、インド、110 070
- Fortis Hospital
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Pune、インド、411030
- Poona hospital and research centre
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Pune、インド、411001
- Jehangir Hospital
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Andhra Pradesh
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Hyderabaad、Andhra Pradesh、インド、500034
- Care hospital
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Hyderabad、Andhra Pradesh、インド、5000003
- Krishna Heart Institute,
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Gujarat
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Ahmedabad、Gujarat、インド、380 006
- Krishna Heart Institute
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Punjab
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Ludhiana、Punjab、インド、141001
- Dayanand Medical College & Hospital
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Tamilnadu
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Vellore、Tamilnadu、インド、632004
- Christian Medical Center (CMC)
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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
説明
Inclusion Criteria:
- The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.
Exclusion Criteria:
- The inability to obtain an informed consent is an exclusion criterion.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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1
The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
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Drug eluting stent implantation stent in the treatment of coronary artery disease
他の名前：
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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 |
時間枠 |
|---|---|
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Stent thrombosis rates as defined by Academic Research Consortium (ARC)
時間枠：Annually through to 3 years
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Annually through to 3 years
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Composite endpoint of cardiac death and myocardial infarction (MI)
時間枠：at 1 year
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at 1 year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Composite rate of cardiac death and any MI (Q-wave and non Q-wave)
時間枠：at 30, 180 days and at 2 and 3 years
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at 30, 180 days and at 2 and 3 years
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Composite rate of all death and any MI (Q-wave and non Q-wave)
時間枠：at 30, 180 days and at 2 and 3 years
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at 30, 180 days and at 2 and 3 years
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Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG)
時間枠：at 30, 180 days and at 2 and 3 years
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at 30, 180 days and at 2 and 3 years
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Death (cardiac death, vascular death, and non-cardiovascular death)
時間枠：at 30, 180 days and at 2 and 3 years
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at 30, 180 days and at 2 and 3 years
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Any MI (Q-wave and non Q-wave)
時間枠：at 30, 180 days and at 2 and 3 years
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at 30, 180 days and at 2 and 3 years
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Major bleeding complications
時間枠：at 14, 30, 180 days and at 1, 2 and 3 years
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at 14, 30, 180 days and at 1, 2 and 3 years
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Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
時間枠：at 14, 30, 180 days and at 1, 2 and 3 years
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at 14, 30, 180 days and at 1, 2 and 3 years
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Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG)
時間枠：at 30, 180 days and at 1, 2 and 3 years
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at 30, 180 days and at 1, 2 and 3 years
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Clinical device and procedural success
時間枠：Acute
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Acute
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Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire
時間枠：at baseline, 180 days, and 1 year
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at baseline, 180 days, and 1 year
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Stent thrombosis
時間枠：24 hours (acute) and 30 days (sub-acute)
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24 hours (acute) and 30 days (sub-acute)
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Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG)
時間枠：30, 180 days and 1, 2 and 3 years
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30, 180 days and 1, 2 and 3 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ashok Seth, MD、Max Devki Devi Heart & Vascular Institute
- 主任研究者：Tejas Patel, MD、Krishna Heart Institute
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
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 (見積もり)
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
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