Effect of DIRECT Transfer to ANGIOsuite on Functional Outcome in Patient With Severe Acute Stroke Treated With Thrombectomy: the Randomized DIRECT ANGIO Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 3-month functional independence
研究概览
简要总结
Rationale: Acute large-vessel strokes, requiring endovascular treatment, are currently being managed through radiology department before being transferred to the angiography room. However, patients with severe neurological deficit have demonstrated even greater benefits from recanalization as the symptom onset-to-reperfusion time is shortened to less than 1 hour. Recent pilot study have shown a benefit in reducing management delays with direct admission to the angiography room and subsequently in increasing functional independence at 3 months. Therefore, the aim is to demonstrate the superiority of the direct angio-suite transfer versus the standard management, in terms of 3-month functional independence, in patients strongly suspected of having a severe ischemic stroke related to acute large-vessel occlusion of the anterior circulation, and treated by mechanical thrombectomy ± intravenous thrombolysis.
Methods and Design: The DIRECT ANGIO trial is a (PROBE) randomized, multicenter, controlled, open-label, blinded endpoint clinical trial.
Study Outcomes: The primary outcome is the rate of patients with 3-month functional independence defined as modified Rankin Scale score ≤2 at 3 months.
详细描述
Methods:
Design: The DIRECT ANGIO trial is a French academic, investigator-initiated, multicenter, controlled, open-label, blinded endpoint, two-arm randomized, clinical trial to compare the effectiveness and safety of direct angio-suite admission versus the standard radiological or emergency departement-based management in ≤85 year-old patients with suspected proximal arterial occlusion lesion.
Patient population: Patients will be recruited in an emergency situation by neurologists and/or neuroradiologists after a rapid neurological examination by the neurologist raising the suspicion of ischemic stroke by proximal occlusion on the patient's arrival and before any imaging.
Inclusion and exclusion criteria: All consecutive patients with the following features are enrolled, under the condition of immediate availability of the angio-suite and the team (Inclusion and exclusion criteria are detailed below).
According to the French laws, the patient's written consent will be sought if able to receive information and express consent, otherwise written consent from relatives present. In case of inability to consent and absence of the relatives, inclusion in an emergency situation by the neurologist or neuroradiologist, then informed consent to follow will be obtained. If the patient dies before the collection of consent(s) for continuation, the non-objection to the use of his data will be sought from the relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 85 years,
- •Rapid neurological examination by the neurologist of the participating centre before randomization,
- •Suffered from acute severe neurological deficit at hospital admission confirmed by neurologist defined as:
- •Unilateral motor deficit with a total score ≥ 5
- •Facial palsy: item 4 of NIHSS (score 0 to 2)
- •Arm: item 5 of NIHSS (score 0 to 4)
- •Leg: item 6 of NIHSS (score 0 to 2) AND
- •Cortical symptom with a total score ≥ 1
- •Language: item 9 of NIHSS (score 0 to 3)
- •Extinction: item 11 of NIHSS (score 0 to 2)
- •Patients who admitted to hospital within 5 hours after symptom onset
- •Known onset time of symptom
- •Only mothership admissions
- •Fully autonomous patient (pre-stroke mRS ≤2)
- •Availability of the angio-suite and endovascular treatment team at the randomization
- •Person affiliated to or beneficiary of a social security plan
排除标准
- •Severe allergy to iodinated contrast agents,
- •Ongoing pregnancy,
- •Breastfeeding,
- •Consent refusal or opposition of the relatives,
- •Individuals under mandatory legal guardianship or unable to consent and whose relatives oppose the research,
- •Any conditions that could hamper the 3-month outcome recording
结局指标
主要结局
3-month functional independence
时间窗: 3 months (±15 days)
modified Rankin Scale assessing functional outcome from complete recovery scored 0 to death scored 6 with dichotomized outcome: mRS score 0-2 (at least independent for all activities of daily living) versus 3-6 (poor outcome) interpretation of mRS : lower is better
次要结局
- Confirmed large-vessel occlusion in the intervention group(per-procedural time)
- the quality of final perfusion(at end of the endovascular procedure)
- the 24-hour clinical improvement(at 24 hours ((±6 hours))
- the blinded 12-month functional outcome(at 12 months (±1 month))
研究者
Benjamin GORY, MD, PhD
Professor (neuroradiologist)
Central Hospital, Nancy, France