Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)
A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
調査の概要
研究の種類
入学 (実際)
連絡先と場所
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:
- The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- Aged between 18 years and 80 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score ≥8 and ≤25.
- Pre-ictal mRS score of 0 or 1.
- Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1 or M2, MCA, or BA with TICI flow of 0-1.
- Confirmation by the interventionalist, after screening CT or MRI, that the treatment site can be accessed with the Neuravi device.
The interventionalist estimates that at least one deployment of the Neuravi device can be completed within 5 hours from the onset of symptoms, or if time of onset of symptoms is unknown or > 5 hours, patients can be included using imaging with the following criteria:
- MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
- CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low CBV present.
Exclusion Criteria:
- Life expectancy of less than 6 months.
- Females who are pregnant or lactating.
- History of severe allergy to contrast medium.
- Has suffered a stroke in the past three months.
- The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0.
- Platelet count < 50,000.
- Glucose < 50 mg/dL.
- Heparin use in previous 24 hours with PTT or ACT > 2X normal.
- Any known hemorrhagic or coagulation deficiency.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- For basilar artery occlusion, extended early ischemic changes as confirmed by pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the midbrain or pons regions on pre-treatment MRI.
- Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma).
- Excessive arterial tortuosity that precludes the study device from reaching the target vessel.
- A proximal stenosis or complete occlusion that cannot, as judged by the responsible interventionalist, be treated safely or which prevents access to the occluded vessel with the Neuravi device.
- Evidence of active infection.
- Known cancer with metastases
- Current use of cocaine or other vasoactive substance.
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
|
他の名前：
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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 |
|---|---|---|
|
Proportion of Revascularisation Following the Use of the Neuravi Device.
時間枠：Day 1
|
Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion |
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Revascularization
時間枠：Day 1
|
Defined as time from groin puncture to visualization of final angiographic result.
|
Day 1
|
|
Mortality Post Procedure
時間枠：7 and 90(±14) days post procedure
|
All procedure related mortality (i.e.
directly traceable to a procedure related SAE).
|
7 and 90(±14) days post procedure
|
|
Serious Adverse Device Related Effects (SADE)
時間枠：24(-8/+12) hours Post Procedure
|
SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.
|
24(-8/+12) hours Post Procedure
|
|
Symptomatic ICH
時間枠：24(-8/+12) hours Post Procedure
|
Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. |
24(-8/+12) hours Post Procedure
|
|
Clinical Outcome at 90 Days
時間枠：90(±14) days Post Procedure
|
A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days. mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms. mRS 1 = No significant disability. mRS 2 = Slight disability. mRS 3 = Moderate disability. mRS 4 = Moderately severe disability. mRS 5 = Severe disability. mRS 6 = Dead. |
90(±14) days Post Procedure
|
|
Rate of New Territory Embolization
時間枠：24(-8/+12) hours Post Procedure
|
Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.
|
24(-8/+12) hours Post Procedure
|
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Evidence of Infarction
時間枠：24(-8/+12) hours Post Procedure
|
Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.
|
24(-8/+12) hours Post Procedure
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Dr. Tommy Andersson、Karolinska Institutet
- 主任研究者：Prof. Dr. Heinrich Mattle、University Hospital Inselspital, Berne
出版物と役立つリンク
便利なリンク
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
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