Advancing Reperfusion Therapy for Ischemic Stroke: Direct Transfer to Angiography Suite for Patients With Suspected Large Vessel Occlusion (ARTS-DTAS)

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Direct Transfer to Angiography Suite (DTAS) for Patients With Suspected Large Vessel Occlusion

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Large Vessel Occlusion
• Intervention / Treatment: Procedure: direct transfer to angiography suite; Procedure: conventional CT/MRI triage strategy

• Study Type: Interventional
• Enrollment (Estimated): 568
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunyun Xiong; Phone Number: 86-10-59978350; Email: xiongyunyun@bjtth.org

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital
      • Contact: Yunyun Xiong; Phone Number: 86-10-59978350; Email: xiongyunyun@bjtth.org
      • Principal Investigator: Yunyun Xiong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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. DSA will be performed, and EVT will be provided for patients with confirmed LVO. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
Active Comparator: 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.	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. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The modified Rankin Scale (mRS) score 0-2 at 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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordinal distribution of modified Rankin Scale (mRS) at 90 days	Ordinal distribution of mRS at 90 days (shift analysis). 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.	90 days
Rates of endovascular treatment		Immediately after the procedure
Door-to-puncture time		Immediately after the procedure
The modified Rankin Scale (mRS) score of 0-1 at 90 days	The proportion of patients with an mRS score of 0-1 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.	90 days
The proportion of successful recanalization	The proportion of successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] 2b50-3) following endovascular treatment	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 stroke-related mortality at 90 days		90 days
The proportion of procedural complications	Vessel perforation, arterial dissection, access site complication requiring surgical repair or blood transfusion, intraprocedural mortality, and other procedure-related complications determined by the Data and Safety Monitoring Board.	Immediately after the procedure
The proportion of serious adverse events (SAEs)	The proportion of SAEs within 90 days	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	In-hospital mortality among participants with a final confirmed diagnosis of non-LVO, assessed from enrollment to hospital discharge.	From start of enrollment until hospital discharge (e.g. up to 7 days)
Length of hospital stay in non-LVO patients	Length of hospital stay among patients with a final confirmed diagnosis of non-LVO, defined as the number of days from enrollment to hospital discharge.	From start of enrollment until hospital discharge (e.g. up to 7 days)
Proportion by discharge destination (non-LVO)	Assessed at hospital discharge among patients with a final confirmed diagnosis of non-LVO. Discharge destination will be reported as proportions: home, transfer to another hospital, or rehabilitation center.	Immediately at hospital discharge
The rate of early neurological improvement at 24 hours	The rate of early neurological improvement at 24 hours after randomization, defined as a National Institute of Health Stroke Scale (NIHSS) score ≤2 or a reduction of ≥8 points from baseline. Scores on the NIHSS range from 0 to 42, with higher scores indicating a greater deficit.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomization-to-imaging time		Immediately after the procedure
Door-to-recanalization time		Immediately after the procedure
Rates of intravenous thrombolysis		immediately after the intravenous thrombolysis
The modified Rankin Scale (mRS) score 0-3 at 90 days	The proportion of patients with an mRS score of 0-3 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.	90 days
The modified Rankin Scale (mRS) score 5-6 at 90 days	The proportion of patients with an mRS score of 5-6 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.	90 days
Change in NIHSS score from baseline to 24 hours after randomization	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating a greater deficit.	24 hours
Change in NIHSS score from baseline to 5-7 days after randomization or hospital discharge	Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline, assessed at hospital discharge or 5-7 days after randomization, whichever occurs first. Scores on the NIHSS range from 0 to 42, with higher scores indicating a greater deficit.	Up to 5-7 days after randomization or hospital discharge, whichever occurs first

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yunyun Xiong, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; ischemic stroke; large vessel occlusion; direct transfer to angiography suite
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2024ZD0527605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No