Neurothrombectomy France (NTF)
Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke
The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible.
NTF The protocol is part of the evaluation process of our clinical practices recommended by the National Health Authority (HAS), in the specific context of mechanical thrombectomy performed in French centers of interventional neuroradiology working with neurovascular units (A V).
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Nantes、フランス、44093
- CHU de Nantes
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Signature of the information notice by the patient or his legal representative
- Age> 18 years
- Clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h
- Thrombosis (TICI 0 or 1) of the carotid T, M1, M1-M2 bifurcation of the basilar artery occlusion in TANDEM ACI / M1.
Exclusion Criteria:
- Pregnant or lactating women
- Rapid improvement of NIHSS (gain of more than 4 points) between two pre-treatment assessments.
- ASPECT score <7 on the scanner or <5 on the diffusion-weighted imaging (DWI)
- Intracranial hemorrhage on imaging
- Inability of clinical evaluations at 3 months
- extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000)
- 0 Refusal to participate in the study
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：ケースのみ
- 時間の展望：見込みのある
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 |
時間枠 |
|---|---|
|
clinical score for handicap (mRS)
時間枠：at 3 months
|
at 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
hemorrhagic complications on postoperative imaging
時間枠：baseline
|
baseline
|
|
|
hemorrhagic complications on postoperative imaging
時間枠：at 1 day
|
at 1 day
|
|
|
physiological parameter : age
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of coronary artery disease
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of arterial hypertension
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of diabetes
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of hypercholesterolemia
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of intracranial stenosis
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of occlusive arterial disease
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of haematological disorders
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
presence of neoplasia
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
NIHSS score
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
ASPECTS score
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
MRI imaging of stroke
時間枠：baseline
|
Factors of good clinical prognosis
|
baseline
|
|
unblocking rate based on the score TICI
時間枠：at 3 months
|
at 3 months
|
|
|
NIHSS evaluation
時間枠：at 24h
|
at 24h
|
|
|
Influence of collaterality score on the NIHSS
時間枠：at 24h
|
at 24h
|
|
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Influence ASPECTS score on the NIHSS
時間枠：at 24h
|
at 24h
|
|
|
Influence ASPECTS score on the NIHSS
時間枠：at 3months
|
at 3months
|
|
|
influence of anesthesia on the NIHSS
時間枠：at 24h
|
at 24h
|
|
|
hemorrhagic complications
時間枠：at 24h
|
at 24h
|
|
|
Influence of hemorrhagic complications on NIHSS
時間枠：at 24h
|
at 24h
|
|
|
Influence of hemorrhagic complications on NIHSS
時間枠：at 3 months
|
at 3 months
|
協力者と研究者
捜査官
- 主任研究者：Hubert DESAL, PU-PH、Nantes university hospital
研究記録日
主要日程の研究
研究開始
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 (推定)
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。