Ischemic StrokeARTS-DTASNCT07460713
Advancing Reperfusion Therapy for Ischemic Stroke: Direct Transfer to Angiography Suite for Patients With Suspected Large Vessel Occlusion
A study testing direct transfer to angiography suite and conventional CT/MRI triage strategy in people with Ischemic Stroke and Large Vessel Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Large Vessel Occlusion
- What is being tested?
- direct transfer to angiography suite and conventional CT/MRI triage strategy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing tiantan hospital
Beijing, Beijing Municipality, 100070
Yunyun Xiong, 86-10-59978350, xiongyunyun@bjtth.org
Yunyun Xiong
About this study
Official title: 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.
- Conditions
- Ischemic Stroke, Large Vessel Occlusion
- Being tested
- direct transfer to angiography suite, conventional CT/MRI triage strategy
- Keywords
- ischemic stroke, large vessel occlusion, endovascular treatment, direct transfer to angiography suite
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct transfer to angiography suiteProcedure or 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 strategyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: conventional CT/MRI triage strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (18)
Rates of endovascular treatment
Measured: Immediately after the procedure
Door-to-puncture time
Measured: 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.
Measured: 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.
Measured: 90 days
The proportion of successful recanalization
The proportion of successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] 2b50-3) following endovascular treatment
Measured: 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.
Measured: 24 hours
Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition)
Measured: 36 hours
The proportion of all-cause mortality at 90 days
Measured: 90 days
The proportion of stroke-related mortality at 90 days
Measured: 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.
Measured: Immediately after the procedure
The proportion of serious adverse events (SAEs)
The proportion of SAEs within 90 days
Measured: 90 days
Time to alternative treatment initiation in non-LVO patients
Measured: Immediately after the intervention
Rates of misclassification as intracranial hemorrhage (ICH), distal vessel occlusion, or stroke mimics in non-LVO patients
Measured: Immediately after the intervention
Time to initiation of antihypertensive therapy, when indicated, in ICH patients
Measured: Immediately after the intervention
Time to achievement of target blood pressure in ICH patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Yunyun Xiong, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460713
- Sponsor's protocol ID
- 2024ZD0527605
- Acronym
- ARTS-DTAS
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Direct Transfer to Angiography Suite (DTAS) for Patients With Suspected Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT07460713
- Acronym / sponsor ID
- ARTS-DTAS / 2024ZD0527605
- Conditions
- Ischemic Stroke, Large Vessel Occlusion
- Keywords
- ischemic stroke, large vessel occlusion, endovascular treatment, direct transfer to angiography suite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct transfer to angiography suite | Experimental | Procedure: direct transfer to angiography suitePatients 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. |
| conventional CT/MRI triage strategy | Active comparator | Procedure: conventional CT/MRI triage strategyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct transfer to angiography suitePatients 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. | Procedure or surgery | direct transfer to angiography suite |
| conventional CT/MRI triage strategyPatients 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. | Procedure or surgery | conventional CT/MRI triage strategy |
Primary outcome
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.
18 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
Time frame: 90 days
The modified Rankin Scale (mRS) score of 0-1 at 90 days
Time frame: 90 days
The proportion of successful recanalization
Time frame: Immediately after the procedure
The rate of early neurological improvement at 24 hours
Time frame: 24 hours
Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition)
Time frame: 36 hours
The proportion of all-cause mortality at 90 days
Time frame: 90 days
The proportion of stroke-related mortality at 90 days
Time frame: 90 days
The proportion of procedural complications
Time frame: Immediately after the procedure
The proportion of serious adverse events (SAEs)
Time frame: 90 days
Time to alternative treatment initiation in non-LVO patients
Time frame: Immediately after the intervention
Rates of misclassification as intracranial hemorrhage (ICH), distal vessel occlusion, or stroke mimics in non-LVO patients
Time frame: Immediately after the intervention
Time to initiation of antihypertensive therapy, when indicated, in ICH patients
Time frame: Immediately after the intervention
Time to achievement of target blood pressure in ICH patients
Time frame: Immediately after the intervention
In-hospital mortality in non-LVO patients
Time frame: From start of enrollment until hospital discharge (e.g. up to 7 days)
Length of hospital stay in non-LVO patients
Time frame: From start of enrollment until hospital discharge (e.g. up to 7 days)
Proportion by discharge destination (non-LVO)
Time frame: Immediately at hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yunyun Xiong principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct transfer to angiography suite and conventional CT/MRI triage strategy in people with Ischemic Stroke and Large Vessel Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunyun Xiong (86-10-59978350, xiongyunyun@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale (mRS) score 0-2 at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.