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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • direct transfer to angiography suite

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

568 Participants
are divided into 2 treatment groups
Group A: direct transfer to angiography suiteExperimental treatment 1 intervention
Group B: conventional CT/MRI triage strategyActive comparator 1 intervention

Trial outcomes

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.

Time frame
90 days

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

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
4

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

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

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

Time frame
24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: