Acute Ischemic StrokePhase 3NCT07670065
Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit
A Phase 3 study testing Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit and Conventional Thrombectomy in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study investigates whether direct transfer to an emergency stroke unit equipped with NeuAngio-CT reduces time to endovascular reperfusion in patients with acute ischemic stroke and suspected intracranial large-vessel occlusion.Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion
- What is being tested?
- Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit and Conventional Thrombectomy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to 15 Oct 2027
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years;
- Clinical diagnosis of acute ischemic stroke eligible for immediate endovascular treatment;
- Time from symptom onset or last known well ≤ 24 hours;
- Intravenous intracranial and cervical CT angiography completed;
- Confirmed target vessel occlusion amenable to endovascular intervention based on intravenous intracranial and cervical CT angiography findings;
- Written informed consent obtained from the patient or their legally authorized representative.
Who cannot join
- Known contrast agent allergy;
- Renal insufficiency with GFR (glomerular filtration rate) < 45 mL/min/1.73 m²;
- History of kidney transplantation;
- Concomitant diabetes mellitus with current use of metformin;
- Women who are pregnant, breastfeeding, or have a positive pregnancy test at admission;
- Refractory hypertension (defined as systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) (Note: patients may be enrolled if blood pressure is successfully reduced and maintained at an acceptable level with antihypertensive therapy);
- Intracranial space-occupying lesion or other conditions deemed unsuitable for endovascular intervention on imaging;
- Any other serious comorbidity or complication that may interfere with study conduct or evaluation.
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
Xuewei Xie, Dr., 59978555, xueweixie@163.com
About this study
Official title: Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit to Reduce Time to Endovascular Reperfusion for Acute Ischemic Stroke
This study investigates whether direct transfer to an emergency stroke unit equipped with NeuAngio-CT reduces time to endovascular reperfusion in patients with acute ischemic stroke and suspected intracranial large-vessel occlusion.Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants will be randomly assigned to one of two groups. In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used.
Read the detailed description
Timely reperfusion is critical for acute ischemic stroke. Current workflows require participants to undergo intracranial and cervical CTA in a CT suite before transfer to the catheterization laboratory, which adds significant delays. Furthermore, conventional intracranial and cervical CTA has limited sensitivity for detecting medium vessel occlusions due to venous contamination and calcification artifacts. We established an emergency stroke unit with NeuAngio-CT, which is sited within the emergency department and integrates clinical assessment, brain imaging, and initial treatment for patients with suspected stroke. It optimizes the thrombectomy workflow by providing a onestop, multimodal diagnostic and therapeutic solution that eliminates patient transfers between CT and the angiography suite. The system enables rapid switching and integration between CT and digital subtraction angiography (DSA) with real-time acquisition and fusion of CT and DSA datasets, yielding more comprehensive and accurate imaging information to support treatment decisions.This is a multicenter, open-label, randomized, parallel-controlled, non-inferiority trial. Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants must have completed a venous head and neck CTA confirming a treatable vessel occlusion. They will be randomly assigned in a 1:1 ratio to the experimental group or the control group.In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used. Safety endpoints include total contrast agent volume, cumulative radiation dose, rate of serious surgical complications within 7 days or before discharge, and incidence of adverse events and serious adverse events. All participants will be assessed on the day of enrollment and at postoperative day 7 or hospital discharge.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Being tested
- Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit, Conventional Thrombectomy
- Keywords
- Sliding CT/DSA, One-stop Management, Mechanical Thrombectomy, Emergency Stroke Care
- 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 Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke UnitDevice
Participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images.
Conventional ThrombectomyDevice
Participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT.
| Study group | Role | What they receive |
|---|---|---|
| Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit | Experimental | Participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. Receives: Device: Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit |
| Conventional Thrombectomy | Placebo comparator | Participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. Receives: Device: Conventional Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture-to-reperfusion time (PRT)
Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.
Measured: immediately after the intervention
Secondary outcomes (8)
Intervention-to-reperfusion time (IRT)
Measured: immediately after the intervention
Procedure duration
Measured: immediately after the intervention
Puncture completion-to-first-recanalization time
Measured: immediately after the intervention
First-pass recanalization rate
Measured: immediately after the intervention
Contrast volume from puncture to end of procedure
Measured: immediately after the intervention
Radiation dose from puncture to end of procedure
Measured: immediately after the intervention
Rate of serious procedural complications at 7 days post-procedure or prior to discharge
Measured: at 7 days or at discharge
Adverse events (AEs) and serious adverse events (SAEs)
Measured: at 7 days or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Zeguang Ren, Dr., Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670065
- Sponsor's protocol ID
- KY2026-102-02
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit to Reduce Time to Endovascular Reperfusion for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07670065
- Acronym / sponsor ID
- KY2026-102-02
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion
- Keywords
- Sliding CT/DSA, One-stop Management, Mechanical Thrombectomy, Emergency Stroke Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 26 Jun 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.
This study investigates whether direct transfer to an emergency stroke unit equipped with NeuAngio-CT reduces time to endovascular reperfusion in patients with acute ischemic stroke and suspected intracranial large-vessel occlusion.Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants will be randomly assigned to one of two groups. In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used.
Detailed description
Timely reperfusion is critical for acute ischemic stroke. Current workflows require participants to undergo intracranial and cervical CTA in a CT suite before transfer to the catheterization laboratory, which adds significant delays. Furthermore, conventional intracranial and cervical CTA has limited sensitivity for detecting medium vessel occlusions due to venous contamination and calcification artifacts. We established an emergency stroke unit with NeuAngio-CT, which is sited within the emergency department and integrates clinical assessment, brain imaging, and initial treatment for patients with suspected stroke. It optimizes the thrombectomy workflow by providing a onestop, multimodal diagnostic and therapeutic solution that eliminates patient transfers between CT and the angiography suite. The system enables rapid switching and integration between CT and digital subtraction angiography (DSA) with real-time acquisition and fusion of CT and DSA datasets, yielding more comprehensive and accurate imaging information to support treatment decisions.This is a multicenter, open-label, randomized, parallel-controlled, non-inferiority trial. Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants must have completed a venous head and neck CTA confirming a treatable vessel occlusion. They will be randomly assigned in a 1:1 ratio to the experimental group or the control group.In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used. Safety endpoints include total contrast agent volume, cumulative radiation dose, rate of serious surgical complications within 7 days or before discharge, and incidence of adverse events and serious adverse events. All participants will be assessed on the day of enrollment and at postoperative day 7 or hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit | Experimental | Device: Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke UnitParticipants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. |
| Conventional Thrombectomy | Placebo comparator | Device: Conventional ThrombectomyParticipants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years;
- Clinical diagnosis of acute ischemic stroke eligible for immediate endovascular treatment;
- Time from symptom onset or last known well ≤ 24 hours;
- Intravenous intracranial and cervical CT angiography completed;
- Confirmed target vessel occlusion amenable to endovascular intervention based on intravenous intracranial and cervical CT angiography findings;
Key exclusion criteria (8 listed)
- Known contrast agent allergy;
- Renal insufficiency with GFR (glomerular filtration rate) < 45 mL/min/1.73 m²;
- History of kidney transplantation;
- Concomitant diabetes mellitus with current use of metformin;
- Women who are pregnant, breastfeeding, or have a positive pregnancy test at admission;
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 Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke UnitParticipants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. | Device | Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit |
| Conventional ThrombectomyParticipants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. | Device | Conventional Thrombectomy |
Primary outcome
Puncture-to-reperfusion time (PRT)
Time frame: immediately after the intervention
Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.
8 secondary outcomes
Intervention-to-reperfusion time (IRT)
Time frame: immediately after the intervention
Procedure duration
Time frame: immediately after the intervention
Puncture completion-to-first-recanalization time
Time frame: immediately after the intervention
First-pass recanalization rate
Time frame: immediately after the intervention
Contrast volume from puncture to end of procedure
Time frame: immediately after the intervention
Radiation dose from puncture to end of procedure
Time frame: immediately after the intervention
Rate of serious procedural complications at 7 days post-procedure or prior to discharge
Time frame: at 7 days or at discharge
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: at 7 days or at 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 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Zeguang Ren, Dr. study director
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 Phase 3 study testing Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit and Conventional Thrombectomy in people with Acute 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 8 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 26 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yongjun Wang, Dr. (59978555, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture-to-reperfusion time (PRT) (time frame: immediately after the intervention). 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 26 Jun 2026.