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

N/ANot Yet RecruitingNCT07460713

Beijing Tiantan Hospital568 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

568

Conditions

Ischemic Stroke Large Vessel Occlusion

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing tiantan hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

Rates of endovascular treatment

Time frame: Immediately after the procedure

Door-to-puncture time

Time frame: Immediately after the procedure

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.

Time frame: 90 days

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.

Time frame: 90 days

The proportion of successful recanalization

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

Time frame: Immediately after the procedure

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.

Central Contacts

Yunyun Xiong

CONTACT

86-10-59978350 xiongyunyun@bjtth.org

Data from ClinicalTrials.gov

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