急性虚血性脳卒中患者における適応型チップカテーテルの安全性と有効性を評価する重要な研究 (PHAST)
急性虚血性脳卒中患者に対する機械的血栓回収術中に使用される適応先端カテーテルの評価を目的とした、ヒトにおける前向きピボタル初回試験
The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Adriana Popovici
- 電話番号：+41 76 396 34 66
- メール：apopovi3@its.jnj.com
研究連絡先のバックアップ
- 名前：Arnaud Nicolas, PhD
- 電話番号：+41 79 517 97 36
- メール：anicolas@its.jnj.com
研究場所
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Heidelberg、ドイツ、69120
- 募集
- Universitaetsklinikum Heidelberg
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Kiel、ドイツ、24105
- 募集
- Universitatsklinikum Schleswig Holstein Kiel
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Mainz、ドイツ、55101
- 募集
- Universitaetsmedizin Mainz
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Solingen、ドイツ、42653
- 募集
- Stadtisches Klinikum Solingen gemeinnutzige GmbH
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Bordeaux、フランス、33076
- 募集
- CHU Bordeaux
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Toulouse、フランス、31059
- 募集
- Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
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Tours、フランス、37000
- 募集
- CHRU de Tours
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Edegem、ベルギー、2650
- 募集
- UZ Antwerpen
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Ghent、ベルギー、9000
- 募集
- Ghent University Hospital
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Leuven、ベルギー、3000
- 募集
- Universitair Ziekenhuis Leuven
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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
説明
Inclusion criteria:
- Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
- Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
- Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
- Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) >= 3
- A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained
Exclusion criteria:
- Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
- Life expectancy less than (<) 90 days prior to stroke onset
- Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
- Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
- Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
- Baseline CT or MRI showing mass effect
- Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
- Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
- Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
- Baseline expanded thrombolysis in cerebral infarction (eTICI) > 1
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：なし
- 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 |
|---|---|
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実験的：Adaptive Tip Catheter (ATC)
The ATC will be used alone (direct aspiration) as the first attempted device/technique for mechanical thrombectomy in the anterior circulation in patients during the first three passes or until final reperfusion, if less than three passes are needed. Patients will be followed over 90 days post procedure. |
Patients will undergo mechanical thrombectomy using ATC. |
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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Third Pass Reperfusion Assessed by Independent Imaging Core Lab
時間枠：Intraoperative
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Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy. |
Intraoperative
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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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First Pass Reperfusion
時間枠：Intraoperative
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Successful achievement of the first pass reperfusion is defined as achieving an eTICI score of 2c or greater, as determined by the independent imaging core lab, with one pass of the study device in the target vessel, and without any rescue therapy. |
Intraoperative
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Final Procedural Reperfusion
時間枠：Intraoperative
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Successful achievement of the final procedural reperfusion is defined as achieving a final (end of procedure) eTICI score of 2b50 or greater in the target vessel as determined by the independent imaging core lab. |
Intraoperative
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Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure
時間枠：At 90 days post-procedure
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Percentage of patients with mRS score of 0-2 at 90 days or no change from baseline if pre-ictal mRS greater than (>) 2 will be reported. |
At 90 days post-procedure
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Vessel Damage
時間枠：At 90 days post-procedure
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Number of patients with perforation or dissection in the blood vessel known to be related to or possibly related to the study device will be reported. |
At 90 days post-procedure
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All-Cause Mortality
時間枠：At 90 days post-procedure
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All mortality regardless of causes at 90 days post-procedure will be reported. |
At 90 days post-procedure
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Symptomatic Intracranial Hemorrhage (sICH) at 24 hours
時間枠：At 24 hours after intervention
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sICH is defined as a new intracranial hemorrhage as detected by brain imaging, measured 24 hours after intervention associated with any of the following: greater than or equal to (>=) 4 points total National Institutes of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; >= 2 point in one NIHSS category; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention or absence of alternative explanation for deterioration. |
At 24 hours after intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Christophe Cognard, MD-PhD、CHU Toulouse - Hôpital, Purpan, Toulouse France
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- CNV202304
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。