Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)
2021年4月9日 更新者：Svelte Medical Systems, Inc.
Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
調査の概要
研究の種類
介入
入学 (実際)
159
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Amsterdam、オランダ
- OLVG Amsterdam
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Eindhoven、オランダ
- Catharina Hospital Eindhoven
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Rotterdam、オランダ
- Maasstad ziekenhuis
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Rotterdam、オランダ
- Erasmus MC
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Utrecht、オランダ
- University Medical Center Utrecht, Department of Cardiology
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Bern、スイス
- Inselspital
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Malmo、スウェーデン
- Skane University Hospital
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Stockholm、スウェーデン
- Södersjukhuset
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Prague、チェコ
- Vseobecna fakultni nemocnice Praha
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Hamburg、ドイツ
- University Medical Center Hamburg-Eppendorf
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Hamburg、ドイツ
- Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer
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Rouen、フランス
- Clinique Saint-Hilaire
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Toulouse、フランス
- CHU de Toulouse
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Toulouse、フランス
- Clinique Pasteur
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Aalst、ベルギー
- OLV Ziekenhuis Aalst
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Antwerpen、ベルギー
- Middelheim Ziekenhuis
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Genk、ベルギー
- ZOL Genk
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Liege、ベルギー
- CHU Liège
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
General Inclusion Criteria
- Patient is ≥18 years old;
- Patient is eligible for percutaneous coronary intervention (PCI);
- Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
- Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
- Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
- Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
- Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
Angiographic Inclusion Criteria
- Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
- Residual diameter stenosis < 30%;
- Absence of any angiographic complications;
- Absence of ischemic symptoms; and
- Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
- Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
- Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
- Target lesion stenosis ≥ 50% and < 100% by visual estimate.
Exclusion Criteria:
General Exclusion Criteria
- Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
- The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
- The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
- Any DES deployment anywhere in the target vessel within the past 9-months;
- Any BMS deployment anywhere in the target vessel within the past 6-months;
- Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
Myocardial infarction within 72-hours of the index procedure, with the exception of:
- Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72-hours;
- Patients who have had a non-STEMI may be included if their troponin levels are within the laboratory normal range within 24-hours pre-procedure.
- Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
- Concurrent medical condition with a life expectancy of less than 12-months;
- Documented left ventricular ejection fraction (LVEF) ≤ 30%;
- Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
- Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
- Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
- Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
- History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
- Patients requiring ongoing anticoagulation with warfarin or dabigatran.
Angiographic Exclusion Criteria
- Total occlusion (TIMI 0 or 1);
- Target vessel has angiographic evidence of thrombus
- Target vessel is excessively tortuous or has heavy calcification;
- Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
- Target lesion is located in or supplied by an arterial or venous bypass graft;
- Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
- Target lesion involves a side branch > 2.0 mm in diameter; and
- Unprotected Left Main coronary disease (stenosis > 50%).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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 |
|---|---|
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実験的：Svelte Drug-Eluting Coronary Stent
Coronary Stenting
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アクティブコンパレータ：Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
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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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Angiographic In-Stent Late Lumen Loss (LL)
時間枠：6-months post-procedure
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Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
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6-months post-procedure
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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 |
|---|---|---|
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Number of Participants Clinically-driven Target Lesion Revascularization (TLR)
時間枠：1 year post-procedure
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Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
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1 year post-procedure
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Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization
時間枠：1 year post-procedure
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Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
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1 year post-procedure
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Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels
時間枠：1 year post-procedure
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Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
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1 year post-procedure
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Number of Participants Stent Thrombosis
時間枠：1 year post-procedure
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The sudden occlusion of a stented coronary artery due to thrombus formation.
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1 year post-procedure
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Number of Participants Acute Success Rates
時間枠：From index procedure to hospital discharge, an average of 24 hours
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Direct Stenting Success, Lesion Success, Procedure Success and Device Failure
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From index procedure to hospital discharge, an average of 24 hours
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Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
時間枠：6-months post-procedure
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The rate which restenosis occurs
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6-months post-procedure
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In-stent and In-segment Minimum Lumen Diameter
時間枠：6-months post-procedure
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Smallest diameter in the stent or segment area
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6-months post-procedure
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In-segment Late Lumen Loss
時間枠：6-months post-procedure
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Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
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6-months post-procedure
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Neointimal Hyperplasia as Measured by OCT
時間枠：6-months post procedures
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(% lumen volume)
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6-months post procedures
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Strut Coverage
時間枠：6-months post procedure
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(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
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6-months post procedure
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Number of Participants Target Vessel Failure
時間枠：1 year post procedure
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Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
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1 year post procedure
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alexandre Abizaid, MD, PhD、Instituto Dante Pazzanese de Cardiologia
- 主任研究者：Stefan Verheye, MD, PhD、Antwerp Cardiovascular Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年1月1日
一次修了 (実際)
2014年5月1日
研究の完了 (実際)
2019年5月31日
試験登録日
最初に提出
2013年2月5日
QC基準を満たした最初の提出物
2013年2月7日
最初の投稿 (見積もり)
2013年2月11日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月4日
QC基準を満たした最後の更新が送信されました
2021年4月9日
最終確認日
2021年4月1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。