BIOFLOW III Satellite-ELADIS Orsiro Stent System
BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
調査の概要
状態
条件
詳細な説明
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Badajoz、スペイン
- Hospital Infanta Cristina
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Barcelona、スペイン
- Hospital Vall d' Hebron
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Cadiz、スペイン
- Hospital G.de Jerez de la Frontera
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Gasteiz / Vitoria、スペイン
- Hospital de Txagorritxu
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Murcia、スペイン
- Hospital Univ. Virgen de la Arrixaca
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Mérida、スペイン
- Hospital de Mérida
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Sabadell、スペイン
- Hospital Parc Tauli
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Santiago de Compostela、スペイン、15702
- Complejo de Hospitalario de Santiago
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Sevilla、スペイン
- Hospital Virgen Del Rocio
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Terrassa、スペイン
- Hospital Mutua de Terrassa
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Valencia、スペイン
- Hospital Clinico de Valencia
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Valencia、スペイン
- Hospital Doctor Peset
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Vizcaya、スペイン、48903
- Hospital de Cruces
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A/Altos de Nava s/n
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León、A/Altos de Nava s/n、スペイン、24080
- Hospital Universitario León
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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
説明
Inclusion Criteria:
- Symptomatic coronary artery disease
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is≥18 years of age.
Exclusion Criteria:
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not yet reached.
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 |
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オルシロ
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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 |
メジャーの説明 |
時間枠 |
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標的病変不全 (TLF)
時間枠:12ヶ月
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心臓死、標的血管Q波または非Q波心筋梗塞(MI)、冠動脈バイパス移植(CABG)、および臨床的に推進される標的病変血行再建術(TLR)の複合。
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12ヶ月
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
TLF
時間枠:6 months
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Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
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6 months
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Target Vessel Revascularization (TVR)
時間枠:6 and 12 months
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Target Vessel Revascularization (TVR)
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6 and 12 months
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Target lesion revascularization (TLR)
時間枠:6 and 12 months
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Target lesion revascularization (TLR)
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6 and 12 months
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Stent Thrombosis rate
時間枠:6 and 12 months
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Stent Thrombosis rate
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6 and 12 months
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Device success
時間枠:up to discharge
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
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up to discharge
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Procedure success
時間枠:up to 7 days after procedure
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Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
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up to 7 days after procedure
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Sonia Martin、CEM BIOTRONIK SA
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
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。
冠動脈疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ