Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Direct Transfer to Angiography Suite (DTAS) for Patients With Suspected Large Vessel Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- The modified Rankin Scale (mRS) score 0-2 at 90 days
研究概览
简要总结
The investigators initiated a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of the direct transfer to angiography suite (DTAS) triage strategy compared to the conventional triage strategy with CT/MRI in patients with suspected large artery occlusive (LVO) within 6 hours of symptom onset.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old;
- •Patients presenting with symptoms or signs suggestive of acute large vessel occlusion (LVO) stroke；
- •Randomization within 6 hours of symptom onset；
- •Baseline NIHSS score ≥10 points prior to randomization;
- •Pre-stroke modified Rankin Scale (mRS) score ≤2;
- •Written informed consent from patients or their legally authorized representatives.
排除标准
- •Refusal of endovascular treatment；
- •Allergy to contrast agents;
- •Clinical symptoms or signs suggestive of intracranial hemorrhage (e.g., severe headache, seizures, or signs of increased intracranial pressure);
- •Transferred patients (e.g., from centers without thrombectomy capability);
- •Seizure at stroke onset, postictal paralysis, or inability or unwillingness to cooperate due to epilepsy or other neurological or psychiatric disorders;
- •Clinically unstable conditions requiring urgent life-support treatment;
- •Other standard contraindications to endovascular treatment;
- •Any terminal illness such that the patient would not be expected to survive more than 1 year;
- •Pregnant women, nursing mothers, or women with a positive pregnancy test at admission;
- •Unlikely to adhere to the trial protocol or follow-up;
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
- •Participation in other interventional clinical trials within the previous 3 months.
研究组 & 干预措施
direct transfer to angiography suite
Patients will bypass the emergency radiology imaging step and be directly transferred to the angiography suite. After screening for intracranial hemorrhage using flat-panel CT, intravenous tenecteplase will be administered according to current guidelines. Digital subtraction angiography (DSA) will be performed, and endovascular treatment (EVT) will be provided for patients with confirmed LVO.
干预措施: direct transfer to angiography suite (Procedure)
conventional CT/MRI triage strategy
Patients will undergo routine imaging, including non-contrast CT/CTA/CTP or MRI/MRA/PWI. For ischemic stroke patients, intravenous tenecteplase will be administered according to current guidelines. Patients with imaging-confirmed LVO will proceed to the angiography suite for further EVT following the standard procedure.
干预措施: conventional CT/MRI triage strategy (Procedure)
结局指标
主要结局
The modified Rankin Scale (mRS) score 0-2 at 90 days
时间窗: 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
次要结局
- Rates of endovascular treatment(Immediately after the procedure)
- Door-to-puncture time(Immediately after the procedure)
- The proportion of stroke-related mortality at 90 days(90 days)
- Ordinal distribution of modified Rankin Scale (mRS) at 90 days(90 days)
- The modified Rankin Scale (mRS) score of 0-1 at 90 days(90 days)
- The proportion of successful recanalization(Immediately after the procedure)
- Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition)(36 hours)
- The proportion of all-cause mortality at 90 days(90 days)
- The proportion of procedural complications(Immediately after the procedure)
- The proportion of serious adverse events (SAEs)(90 days)
- Time to alternative treatment initiation in non-LVO patients(Immediately after the intervention)
- Rates of misclassification as intracranial hemorrhage (ICH), distal vessel occlusion, or stroke mimics in non-LVO patients(Immediately after the intervention)
- Time to initiation of antihypertensive therapy, when indicated, in ICH patients(Immediately after the intervention)
- Time to achievement of target blood pressure in ICH patients(Immediately after the intervention)
- In-hospital mortality in non-LVO patients(From start of enrollment until hospital discharge (e.g. up to 7 days))
- Length of hospital stay in non-LVO patients(From start of enrollment until hospital discharge (e.g. up to 7 days))
- Proportion by discharge destination (non-LVO)(Immediately at hospital discharge)
- The rate of early neurological improvement at 24 hours(24 hours)
研究者
Yunyun Xiong
Professor
Beijing Tiantan Hospital