- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02880579
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).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nantes, 프랑스, 44093
- CHU de Nantes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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clinical score for handicap (mRS)
기간: at 3 months
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at 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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hemorrhagic complications on postoperative imaging
기간: baseline
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baseline
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hemorrhagic complications on postoperative imaging
기간: at 1 day
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at 1 day
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physiological parameter : age
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of coronary artery disease
기간: baseline
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Factors of good clinical prognosis
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baseline
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presence of arterial hypertension
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of diabetes
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of hypercholesterolemia
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of intracranial stenosis
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of occlusive arterial disease
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of haematological disorders
기간: baseline
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Factors of good clinical prognosis
|
baseline
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presence of neoplasia
기간: baseline
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Factors of good clinical prognosis
|
baseline
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NIHSS score
기간: baseline
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Factors of good clinical prognosis
|
baseline
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ASPECTS score
기간: baseline
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Factors of good clinical prognosis
|
baseline
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MRI imaging of stroke
기간: baseline
|
Factors of good clinical prognosis
|
baseline
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unblocking rate based on the score TICI
기간: at 3 months
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at 3 months
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NIHSS evaluation
기간: at 24h
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at 24h
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Influence of collaterality score on the NIHSS
기간: at 24h
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at 24h
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Influence ASPECTS score on the NIHSS
기간: at 24h
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at 24h
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Influence ASPECTS score on the NIHSS
기간: at 3months
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at 3months
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influence of anesthesia on the NIHSS
기간: at 24h
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at 24h
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hemorrhagic complications
기간: at 24h
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at 24h
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Influence of hemorrhagic complications on NIHSS
기간: at 24h
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at 24h
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Influence of hemorrhagic complications on NIHSS
기간: at 3 months
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at 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hubert DESAL, PU-PH, Nantes university hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .