Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07460713

Advancing Reperfusion Therapy for Ischemic Stroke: Direct Transfer to Angiography Suite 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Large Vessel Occlusion Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location contact

Yunyun Xiong

CONTACT

[email protected]

86-10-59978350

Yunyun Xiong

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

direct transfer to angiography suite

Procedure

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.

conventional CT/MRI triage strategy

Procedure

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.

Primary outcomes

  1. The modified Rankin Scale (mRS) score 0-2 at 90 days

    Time frame: 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.

Secondary outcomes

  1. Rates of endovascular treatment

    Time frame: Immediately after the procedure

  2. Door-to-puncture time

    Time frame: Immediately after the procedure

  3. Ordinal distribution of modified Rankin Scale (mRS) at 90 days

    Time frame: 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.

  4. The modified Rankin Scale (mRS) score of 0-1 at 90 days

    Time frame: 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.

  5. The proportion of successful recanalization

    Time frame: Immediately after the procedure

    The proportion of successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] 2b50-3) following endovascular treatment

  6. The rate of early neurological improvement at 24 hours

    Time frame: 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.

  7. Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition)

    Time frame: 36 hours

  8. The proportion of all-cause mortality at 90 days

    Time frame: 90 days

  9. The proportion of stroke-related mortality at 90 days

    Time frame: 90 days

  10. The proportion of procedural complications

    Time frame: Immediately after the procedure

    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.

  11. The proportion of serious adverse events (SAEs)

    Time frame: 90 days

    The proportion of SAEs within 90 days

  12. Time to alternative treatment initiation in non-LVO patients

    Time frame: Immediately after the intervention

  13. Rates of misclassification as intracranial hemorrhage (ICH), distal vessel occlusion, or stroke mimics in non-LVO patients

    Time frame: Immediately after the intervention

  14. Time to initiation of antihypertensive therapy, when indicated, in ICH patients

    Time frame: Immediately after the intervention

  15. Time to achievement of target blood pressure in ICH patients

    Time frame: Immediately after the intervention

  16. In-hospital mortality in non-LVO patients

    Time frame: From start of enrollment until hospital discharge (e.g. up to 7 days)

    In-hospital mortality among participants with a final confirmed diagnosis of non-LVO, assessed from enrollment to hospital discharge.

  17. Length of hospital stay in non-LVO patients

    Time frame: From start of enrollment until hospital discharge (e.g. up to 7 days)

    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.

  18. Proportion by discharge destination (non-LVO)

    Time frame: Immediately at hospital discharge

    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.

Other outcomes

  1. Randomization-to-imaging time

    Time frame: Immediately after the procedure

  2. Door-to-recanalization time

    Time frame: Immediately after the procedure

  3. Rates of intravenous thrombolysis

    Time frame: immediately after the intravenous thrombolysis

  4. Change in NIHSS score from baseline to 24 hours after randomization

    Time frame: 24 hours

    Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating a greater deficit.

  5. Change in NIHSS score from baseline to 5-7 days after randomization or hospital discharge

    Time frame: Up to 5-7 days after randomization or hospital discharge, whichever occurs first

    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.

  6. The modified Rankin Scale (mRS) score 0-3 at 90 days

    Time frame: 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.

  7. The modified Rankin Scale (mRS) score 5-6 at 90 days

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunyun Xiong

CONTACT

[email protected]

86-10-59978350

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: ARTS-DTAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.