新世代の Flow Diverter で動脈瘤治療を最適化するコーティング (COATING)
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Birmingham、イギリス、B15 2GW
- Queen Elisabeth Hospital Birmingham
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Edinburgh、イギリス
- Western General Hospital
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Jerusalem、イスラエル、9112001
- Hadassah University Medical Center
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Milan、イタリア、20133
- Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
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Basel、スイス、4051
- Universitätsspital Basel
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Košice、スロバキア、04190
- UNLP Košice
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Augsburg、ドイツ、86156
- Universitätsklinikum Augsburg
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Erfurt、ドイツ、99089
- Helios Klinikum Erfurt
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Halle、ドイツ、06120
- Universitätsklinikum Halle (Saale)
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München、ドイツ、81377
- Klinikum der LMU München
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Nuremberg、ドイツ、90471
- Klinikum Nürnberg Süd
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Recklinghausen、ドイツ
- Klinikum Vest Recklinghausen
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Stuttgart、ドイツ、70174
- Klinikum Stuttgart
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Bordeaux、フランス、33076
- CHU Bordeaux
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Le Kremlin-Bicêtre、フランス、94270
- Hôpital Bicêtre
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Lyon、フランス、69002
- CHU de Lyon
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Montpellier、フランス、34090
- CHU de Montpellier
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Reims、フランス、51092
- CHU Reims - Hôpital Maison Blanche
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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:
- At least 18 years of age.
- Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
- Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
- Subject has already been selected for flow diversion therapy as the appropriate treatment.
- Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
- Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).
Exclusion Criteria:
- Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
- Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
- Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
- Subject with target aneurysm previously treated with a stent or flow diverter.
- Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
- Subject with a confirmed stenosis in parent artery.
- Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
- Subject has a pre-procedure mRS >2.
- Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
- Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
- Known serious sensitivity to radiographic contrast agents.
- Known sensitivity to nickel, titanium metals, or their alloys.
- Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
- Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
- Subject who has a contraindication to MRI or angiography for whatever reason.
- Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- Subject with any known allergy to heparin, ASA or other antiplatelet medications.
- Subject with coagulation disorder
- Pregnant woman or breast feeding.
- Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
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：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：p64 MW HPC フローダイバータ + SAPT
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Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device. |
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実験的：p64 MW フローダイバータ + DAPT
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Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device. |
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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Number of DWI lesions
時間枠：48 hours (± 24 hours)
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Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI. |
48 hours (± 24 hours)
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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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Short-term morbi-mortality rate
時間枠：30 days (± 7 days)
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Morbi-mortality rate at 30 days assessed by mRS > 2 |
30 days (± 7 days)
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Rate of neurological death or major stroke
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Long-term morbi-mortality rate
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of subjects with dissusion-weighted imaging (DWI) lesions
時間枠：48 hours (± 24 hours)
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Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke |
48 hours (± 24 hours)
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Delayed aneurysm rupture
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Delayed intraparenchymal hemorrhage
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of peripheral bleeding
時間枠：Any event reported from discharge to 365 days (335 - 456 days) post procedure
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Rate of peripheral bleeding, as assessed by the Clinical Events Committee |
Any event reported from discharge to 365 days (335 - 456 days) post procedure
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Rate of device deployment at the target site without technical complications
時間枠：During intervention
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Rate of device deployment at the target site without technical complications, as assessed by the site |
During intervention
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Rate of complete aneurysm occlusion
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm recurrence
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm retreatment
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of intrastent stenosis and/or thrombosis at the target site
時間枠：180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA |
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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Mean length of hospital stay
時間枠：From admission up to discharge, assessed up to 456 days
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Mean length of hospital stay (from hospital admission and up to hospital discharge) |
From admission up to discharge, assessed up to 456 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Laurent Pierot, Prof. Dr.、CHRU Hôpital Maison-Blanche
出版物と役立つリンク
一般刊行物
- Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspotter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24.
- Ramirez-Velandia F, Enriquez-Marulanda A, Filo J, Young M, Fodor TB, Sconzo D, Muram S, Granstein JH, Shutran M, Taussky P, Ogilvy CS. Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis. Neurosurgery. 2024 Aug 1;95(2):330-338. doi: 10.1227/neu.0000000000002883. Epub 2024 Feb 23.
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 (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
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。