NCT07460713

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

January 4, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

March 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 4, 2026

Last Update Submit

March 10, 2026

Conditions

Ischemic StrokeLarge Vessel Occlusion

Keywords

ischemic strokelarge vessel occlusionendovascular treatmentdirect transfer to angiography suite

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Rates of endovascular treatment

    Immediately after the procedure

  • Door-to-puncture time

    Immediately after the procedure

  • 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

  • +13 more secondary outcomes

Other Outcomes (7)

  • 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

  • +4 more other outcomes

Study Arms (2)

direct transfer to angiography suite

EXPERIMENTAL

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

conventional CT/MRI triage strategy

ACTIVE COMPARATOR

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

Interventions

direct transfer to angiography suitePROCEDURE

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.

direct transfer to angiography suite
conventional CT/MRI triage strategyPROCEDURE

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.

conventional CT/MRI triage strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tiantan hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yunyun Xiong

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Xiong

CONTACT

86-10-59978350xiongyunyun@bjtth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2026

First Posted

March 10, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

March 12, 2026

Record last verified: 2026-01

Locations

CN(1)