The E-SERIES Registry for Supralimus® Coronary Stent for the Treatment of Unselected Patients With Coronary Lesions
A Prospective, Multinational Investigation of the Supralimus® Sirolimus-Eluting Stent for the Treatment of Unselected Patients With Coronary Lesions in the "Real- World" Clinical Practice
調査の概要
詳細な説明
E-SERIES Registry is Prospective, multinational (Asia, South America and Europe), non-randomized, post-marketing web-based registry.
For this Study Up to 100 clinical sites in Asia, South America and Europe. Patients "ALL COMERS" assigned for percutaneous coronary interventions who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with the Supralimus® SES.
All subjects who provided signed informed consent prior to procedure, and have at least one lesion in a major epicardial vessel or major branch (>2.25mm), and are suitable for percutaneous treatment including stenting procedure with the Supralimus® SES. There are no limit regarding the number of lesions and/or study stents to be used, and stenting technique will be left at the operator's discretion; however, it is recommended according to the BEST interventional practice according to the current guidelines.
All patients will undergo follow-up clinical evaluation at 1, 6, 12 and 24 months. Angiographic follow-up will be performed at 6 months in a subset of high risk lesions including bifurcations (first 100 lesions) and left main stem (first 100 lesions).
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
São Paulo、ブラジル、05022-001
- Hospital São Camilo
-
-
Espírito Santo
-
Vitória、Espírito Santo、ブラジル、29047-575
- CIAS- Unimed Vitória
-
-
Goiás
-
Goiânia、Goiás、ブラジル、74823-320
- Centro de Cardiologia e Radiologia
-
-
Minas Gerais
-
Belo Horizonte、Minas Gerais、ブラジル、30380-090
- Hospital Luxemburgo
-
Juiz de Fora、Minas Gerais、ブラジル、36025-550
- Hospital Monte Sinai
-
-
Paraná
-
Curitiba、Paraná、ブラジル
- Hospital Vita
-
-
Sao Paulo
-
Botucatu、Sao Paulo、ブラジル
- H.C.Unesp
-
-
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:
- CLINICAL INCLUSION CRITERIA: Patients >18 years, clinical indication for elective or emergency percutaneous coronary intervention with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups.
- ANGIOGRAPHIC INCLUSION CRITERIA: Diseased coronary vessels with at least one lesion with ≥50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (>2.25mm) with anatomy suitable for percutaneous treatment with the Supralimus SES.
Exclusion Criteria:
- CLINICAL EXCLUSION CRITERIA: Known illness with life expectancy <12 months; impossibility to comply with all protocol follow-ups.
- ANGIOGRAPHIC EXCLUSION CRITERIA: Anatomy unsuitable for percutaneous treatment with implantation of the Supralimus SES.
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Supralimus® Sirolimus-Eluting Coronary Stent
|
Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2
他の名前：
|
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 |
|---|---|
|
MAJOR ADVERSE CARDIAC EVENTS (MACE)
時間枠：12 months
|
12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Rates of procedural success
時間枠：24 month
|
24 month
|
|
Rates of Major Adverse Cardiac Event (MACE)
時間枠：In-hospital, 30 days, 6 and 24 months
|
In-hospital, 30 days, 6 and 24 months
|
|
Rates of target lesion revascularization (TLR)
時間枠：6 and 12 months
|
6 and 12 months
|
|
Rates of stent thrombosis (acute, sub-acute, late and very-late)
時間枠：Up to 24 months follow-up
|
Up to 24 months follow-up
|
協力者と研究者
捜査官
- 主任研究者：Alexandre Abizaid,, MD、Instituto Dante Pazzanese de Cardiologia São Paulo, SP, Brazil
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
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。