Stroke AcuteNCT06654375
Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography
A study testing Endovascular Thrombectomy in people with Stroke Acute and Thrombectomy, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute, Thrombectomy, Medical Treatment
- What is being tested?
- Endovascular Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 31 Dec 2027
- 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
- Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions.
- Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.
- The patient must be aged 18 years or older.
- The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization.
- Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints).
- There must be no significant pre-stroke disability, as indicated by a pre-baseline modified Rankin Scale score of 0-2.
- The patient must be willing and able to return for the protocol-required follow-up visits.
- The patient or their legally authorized representative must have signed the Informed Consent form.
Who cannot join
- The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months.
- The subject has a pre-existing medical, neurological, or psychiatric disease that would interfere with neurological or functional evaluations, or is already participating in another drug or device study.
- The subject is pregnant.
- The subject has contraindications for both MRI and CT contrast that prevent an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist.
- The subject has a known allergy to iodine and has previously been refractory to pretreatment medications.
- The subject has been treated with tPA more than 4.5 hours after the last known well time.
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- The subject has a known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or has recently undergone oral anticoagulant therapy with an INR greater than 3.
- The subject has symptoms consistent with stroke in multiple locations.
- The subject has seizures at stroke onset, which makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
- The subject has a baseline blood glucose level of less than 50mg/dL (2.78 mmol) or greater than 400mg/dL (22.20 mmol).
- The subject has a baseline platelet count of less than 50,000/uL.
- The subject has severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) that is not treatable with medications.
- The subject is currently participating in another investigational drug or device study or registry.
- The subject is presumed to have a septic embolus, suspicion of bacterial endocarditis, or cerebral vasculitis.
- The subject has had clot retrieval attempted using a neurothrombectomy device within 24 hours of symptom onset.
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, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300070
Ming Wei, MD, PhD, 022-13502182903, drweiming@163.com
Ming Wei, MD, PhD
About this study
Official title: Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial
The goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are:
- Can EVT improve functional independence at 90 days for patients treated after 24 hours?
- What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits.
Read more
Participants will:
- Receive either EVT or BMM based on their eligibility.
- Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO.
- Be followed for 90 days to evaluate functional outcomes and safety measures.
- Conditions
- Stroke Acute, Thrombectomy, Medical Treatment, Large Vessel Occlusion
- Being tested
- Endovascular Thrombectomy
- Keywords
- CTA, Endovascular Thrombectomy, Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyProcedure or surgery
Endovascular thrombectomy (EVT) in this clinical trial involves the mechanical removal of a thrombus from a blocked large cerebral artery using specialized devices like stent retrievers or aspiration catheters. Key distinguishing features of this EVT protocol include:
- Extended Time Window: Unlike standard EVT, which is typically performed within 24 hours after symptom onset, this intervention targets patients presenting beyond 24 hours.
- Collateral Circulation Assessment: Multi-phase CT angiography (CTA) is employed to evaluate collateral flow, prioritizing patients with favorable collateral grades. This selection process helps ensure the identification of patients most likely to benefit from EVT despite the late presentation.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular thrombectomy | Experimental | Not described Receives: Procedure: Endovascular Thrombectomy |
| Best Medical Management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days (± 14 days)
Secondary outcomes (10)
extended treatment in cerebral ischemia (eTICI) score
Measured: during EVT procedure
recanalization rate
Measured: 24 hours after randomization, assessed using Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA)
score on the NIHSS
Measured: 24 hours after randomization, 5 to 7 days after randomization, or at discharge, whichever occurs first
final infarct volume on MRI
Measured: 24 hours after randomization on MRI
dichotomized mRS score of 0-1 vs 2-6
Measured: at 90 days
dichotomized mRS score of of 0-2 vs 3-6
Measured: at 90 days
dichotomized mRS score of 0-3 vs 4-6
Measured: at 90 days
death
Measured: at 90 days
Score on the Barthel Index
Measured: at 90 days
Score on the EQ-5D-5L
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start25 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654375
- Sponsor's protocol ID
- tjhh202410
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombectomy Versus Best Medical Management in Large Vessel Occlusion Stroke Patients Presenting Beyond 24 Hours and With Presence of Collateral Flow on CT Angiography: A Multicentre, Open-label, Registry-linked, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06654375
- Acronym / sponsor ID
- tjhh202410
- Conditions
- Stroke Acute, Thrombectomy, Medical Treatment, Large Vessel Occlusion
- Keywords
- CTA, Endovascular Thrombectomy, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Oct 2024 (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 goal of this clinical trial is to investigate if endovascular treatment (EVT) can effectively treat patients with large vessel occlusion (LVO) who present beyond the typical 24-hour window after symptom onset. The main questions it aims to answer are:
- Can EVT improve functional independence at 90 days for patients treated after 24 hours?
- What is the safety profile of EVT in this delayed treatment group compared to best medical management (BMM)? Researchers will compare EVT outcomes in patients presenting after 24 hours to those receiving BMM to see if EVT offers significant benefits.
Participants will:
- Receive either EVT or BMM based on their eligibility.
- Undergo CT angiography to assess collateral circulation and to confirm the presence of LVO.
- Be followed for 90 days to evaluate functional outcomes and safety measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular thrombectomy | Experimental | Procedure: Endovascular Thrombectomy |
| Best Medical Management | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmation of ICA or MCA-M1 occlusion, as detected by MRA or CTA, with carotid occlusions potentially occurring in either the cervical or intracranial regions, and the possibility of accompanying tandem MCA lesions.
- Demonstration of moderate to good collateral flow, as evidenced by CTA imaging.
- The patient must be aged 18 years or older.
- The baseline NIHSSS score is equal to or greater than 2, and this score remains equal to or greater than 2 immediately prior to randomization.
- Endovascular treatment can be initiated (via femoral puncture) within a window of 24 to 72 hours from the onset of the stroke. The onset of the stroke is defined as the time the patient was last known to be at their neurologic baseline (patients with wake-up strokes are eligible if they meet the aforementioned time constraints).
Key exclusion criteria (15 listed)
- The subject has a serious, advanced, or terminal illness (as determined by the investigator) or a life expectancy of less than six months.
- The subject has a pre-existing medical, neurological, or psychiatric disease that would interfere with neurological or functional evaluations, or is already participating in another drug or device study.
- The subject is pregnant.
- The subject has contraindications for both MRI and CT contrast that prevent an MRI or CT contrast perfusion study. The hospital's local standard criteria should be applied to determine if contraindications exist.
- The subject has a known allergy to iodine and has previously been refractory to pretreatment medications.
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 |
|---|---|---|
| Endovascular ThrombectomyEndovascular thrombectomy (EVT) in this clinical trial involves the mechanical removal of a thrombus from a blocked large cerebral artery using specialized devices like stent retrievers or aspiration catheters. Key distinguishing features of this EVT protocol include: * Extended Time Window: Unlike standard EVT, which is typically performed within 24 hours after symptom onset, this intervention targets patients presenting beyond 24 hours. * Collateral Circulation Assessment: Multi-phase CT angiography (CTA) is employed to evaluate collateral flow, prioritizing patients with favorable collateral grades. This selection process helps ensure the identification of patients most likely to benefit from EVT despite the late presentation. | Procedure or surgery | Endovascular thrombectomy |
Primary outcome
modified Rankin Scale
Time frame: 90 days (± 14 days)
a 7-point scale ranging from 0 (no symptoms) to 6 (death)
10 secondary outcomes
extended treatment in cerebral ischemia (eTICI) score
Time frame: during EVT procedure
recanalization rate
Time frame: 24 hours after randomization, assessed using Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA)
score on the NIHSS
Time frame: 24 hours after randomization, 5 to 7 days after randomization, or at discharge, whichever occurs first
final infarct volume on MRI
Time frame: 24 hours after randomization on MRI
dichotomized mRS score of 0-1 vs 2-6
Time frame: at 90 days
dichotomized mRS score of of 0-2 vs 3-6
Time frame: at 90 days
dichotomized mRS score of 0-3 vs 4-6
Time frame: at 90 days
death
Time frame: at 90 days
Score on the Barthel Index
Time frame: at 90 days
Score on the EQ-5D-5L
Time frame: at 90 days
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 23 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Thrombectomy in people with Stroke Acute and Thrombectomy, run by Tianjin Huanhu 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Oct 2024. 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 Ming Wei, MD, PhD (13502182903, drweiming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 90 days (± 14 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 23 Oct 2024.