Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions (NEVO RES-I)
A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution Versus the TAXUS Liberte Paclitaxel-eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent.
While Cordis made a business decision to no longer pursue NEVO™ development and commercialization, the patients will be followed up as per protocol. This includes performing all protocol required follow-up visits and the collection and reporting of all safety information.
調査の概要
状態
詳細な説明
Restenosis remains a frequent cause of late failure following successful coronary angioplasty occurring in an estimated 20-40% of procedures performed. Coronary stents provide mechanical scaffolding that helps reduce restenosis by limiting the extent of elastic recoil and late vascular remodeling. Despite improvements over balloon angioplasty alone, restenosis following coronary stenting procedures has been cited to occur in 20-40% of cases and is primarily a result of neointimal hyperplasia. Thus, stents which are capable of delivering drugs to limit neointimal hyperplasia, in addition to providing mechanical support at the area of the lesion, have been developed to further limit the extent of restenosis following coronary stenting. There are several pharmacologic agents approved for use with drug-eluting stents.Two drugs have been widely studied in controlled clinical trials and real-world patient populations, sirolimus and paclitaxel.
This study will evaluate a new sirolimus-eluting cobalt chromium coronary stent system compared to an approved paclitaxel-eluting coronary stent system in the treatment of single de novo coronary lesions in native coronary arteries. Subjects meeting qualification will be randomized in a 1:1 fashion to treatment with the Conor sirolimus-eluting coronary stent or to treatment with an approved paclitaxel-eluting coronary stent. All subjects will undergo angiographic follow-up at six months and complete clinical follow-up for a period of five years.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
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:
- 18 years of age or older
- Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
- Diagnosis of stable or unstable angina or silent ischemia
- Left ventricular ejection fraction >30%
- The subject requires treatment of a single de novo lesion in a native coronary artery.
- Lesion to be treated is less than or equal to 28 mm in length in a vessel that is 2.5-3.5mm diameter.
- The target lesion diameter stenosis is >50% and <100% by visual estimate.
- The target lesion is a minimum of 10 mm distance from any previously treated segment of the target vessel.
- The subject understands the study requirements, is willing to comply with all study procedures and has provided written informed consent.
Exclusion Criteria:
- The subject has undergone coronary revascularization to any vessel within 30 days.
- The subject has undergone target vessel revascularization within 6 months.
- Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
- The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
- There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
- The subject had a myocardial infarction within 72 hours, or presents with CK elevation > 2 times upper limit normal associated with elevated CK-MB.
- The subject is in cardiogenic shock.
- The subject had a cerebrovascular accident within the past 6 months.
- The subject has acute or chronic renal dysfunction (defined as creatinine >2.0 mg/dl).
- The subject has a contraindication to aspirin or clopidogrel.
- The subject has thrombocytopenia (platelet count < 100,000/mm3.
- The subject has had active gastrointestinal bleeding within the past 3 months.
- The subject has a known bleeding or hypercoagulable disorder.
- The subject has had prior anaphylactoid reaction to contrast agents or has contrast sensitivity that cannot be controlled with pre-medication.
- The subject is currently taking immunosuppressant therapy.
- The subject is currently, or has been treated wtih either Rapamune or paclitaxel within 12 months of the procedure.
- The subject is a female with a positive pregnancy test or is lactating.
- The subject has an active infection.
- The subject has co-morbidities that could interfere wtih completion of study procedures, or life expectancy less than 24 months.
- The subject is participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
Angiographic Exclusion Criteria
- Left main disease >50% diameter stenosis.
- The target lesion is ostial.
- The target lesion or target vessel are severely calcified.
- The target lesion involves a bifurcation with diseased branch vessel greater than or equal to 2.0 mm that would require intervention or protection.
- The target lesion has TIMI o or TIMI I flow.
- Angiographic evidence of thrombus.
- The target vessel has had prior stent placement.
- The patient has had prior coronary brachytherapy.
- There is angiographic restenosis of any previously treated segment of the target vessel, or atherosclerotic area wtih >50% diameter stenosis outside of the target lesion.
- The subject has undergone prior CABG.
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Investigational arm
Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
|
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques.
Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System.
Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
|
アクティブコンパレータ:Control Arm
Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.
|
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques.
Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.
Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
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 |
---|---|
Angiographic endpoint of in-stent late lumen loss as measured by QCA.
時間枠:6 months
|
6 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Target Lesion Failure defined as cardiac death that cannot be clearly attributed to a non-cardiac event or non-target vessel, target vessel related myocardial infarction or clinically driven target lesion revascularization.
時間枠:hospital discharge, 30 days, 6 months and annually through five years.
|
hospital discharge, 30 days, 6 months and annually through five years.
|
Target Vessel Failure defined as any myocardial infarction or cardiac death that cannot be attributed to a non-target vessel or any target vessel revascularization.
時間枠:Hospital discharge, 30 days, 6 months and annually through five years
|
Hospital discharge, 30 days, 6 months and annually through five years
|
Major Adverse Cardiac Events defined as an adjudicated composite of death, emergent coronary artery bypass graft surgery, target lesion revascularization, or new myocardial infarction.
時間枠:Hospital discharge, 30 days, 6 months and annually through five years
|
Hospital discharge, 30 days, 6 months and annually through five years
|
Incidence of stent thrombosis
時間枠:Hospital discharge, 30 days, 6 months and annually through five years
|
Hospital discharge, 30 days, 6 months and annually through five years
|
Incidence of target lesion revascularization and target vessel revascularization.
時間枠:Hospital discharge, 30 days, 6 months and annually through five years
|
Hospital discharge, 30 days, 6 months and annually through five years
|
Device Success
時間枠:Procedural
|
Procedural
|
Lesion success
時間枠:Procedural
|
Procedural
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Procedure Success
時間枠:Hospital Discharge
|
Hospital Discharge
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Angiographic in-stent and in-segment binary restenosis.
時間枠:6 months
|
6 months
|
In-stent minimum lumen diameter
時間枠:6 months
|
6 months
|
Percent volume obstruction of the stent by intravascular ultrasound evaluation
時間枠:6 months
|
6 months
|
Patient reported outcomes as measured by three standardized quality of life surveys.
時間枠:Baseline, 30 days, 6 months and 12 months
|
Baseline, 30 days, 6 months and 12 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:John Ormiston, MB ChM、Mercy Angiography Unit
- 主任研究者:Alexandre Abizaid, MD. PhD、Instituto Dante Pazzanese de Cardiologia
出版物と役立つリンク
一般刊行物
- Ormiston JA, Abizaid A, Spertus J, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Dubois C, Hoffmann R, Wijns W, Fitzgerald PJ, Popma JJ, Macours N, Cebrian A, Stoll HP, Rogers C, Spaulding C; NEVO ResElution-I Investigators. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2010 Dec;3(6):556-64. doi: 10.1161/CIRCINTERVENTIONS.110.946426. Epub 2010 Nov 9. Erratum In: Circ Cardiovasc Interv. 2011 Feb 1;4(1):e4.
- Otake H, Honda Y, Courtney BK, Shimohama T, Ako J, Waseda K, Macours N, Rogers C, Popma JJ, Abizaid A, Ormiston JA, Spaulding C, Cohen SA, Fitzgerald PJ. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberte stents in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.
- Abizaid A, Ormiston JA, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Macours N, Qureshi AC, Spaulding C; NEVO ResElution-I Investigators. Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. EuroIntervention. 2013 Oct;9(6):721-9. doi: 10.4244/EIJV9I6A116.
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CP-06
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。
NEVO™ Sirolimus-eluting Coronary Stent Systemの臨床試験
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Medtronic Vascular完了
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Instituto Nacional de Cardiologia Ignacio Chavez募集
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Biotronik (Beijing) Medical Device Ltd.Biotronik AG招待による登録
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Concept Medical Inc.積極的、募集していない冠動脈疾患 | 糖尿病 | 急性冠症候群スイス, オーストラリア, 大韓民国, フランス, ベルギー, オランダ, イギリス, インド, オーストリア, バングラデシュ, ブラジル, チェコ, ドイツ, アイルランド, イタリア, マレーシア, メキシコ, ポーランド, シンガポール, スウェーデン, 台湾
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Scitech Produtos Medicos Ltdaわからない
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Robbert J de Winterわからない