Large Vessel OcclusionNCT06260969
Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis
An observational study of Large Vessel Occlusion and Intracranial Artery Occlusion With Cerebral Infarction, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Vessel Occlusion, Intracranial Artery Occlusion With Cerebral Infarction, Endovascular Treatments
- What is being tested?
- balloon dilatation
- Type of treatment
- Medical device
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Sep 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with acute cerebral infarction with underlying intracranial artery stenosis receiving endovascular treatment
Who may be able to join
- CT scan to exclude intracranial haemorrhage；CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography showing occlusion of the distal intracranial carotid artery or the first segment of the middle cerebral artery；ELVO with a base ICAS of > 70%；Mechanical thrombectomy within 6h after symptom onset in ischemic stroke；NIHSS≥6；receiving endovascular treatments；informed consent form signed by the patient or their legal representatives.
Who cannot join
- Hemorrhagic body, coagulation factor deficiency or oral anticoagulant therapy(INR > 3.0)；Baseline platelet count <50,000/µL；Baseline blood glucose <50mg/dL or >400mg/dL；Intractable hypertension(systolic blood pressure >220 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by medication；Patients intubated without a NIHSS score assessed by a neurologist or emergency physician prior to intubation；Stroke attack with epilepsy affecting baseline NIHSS score；End-stage diseases leading to less than one year of expected survival for patients；Severe allergy to contrast media；Patients with renal insufficiency (blood creatinine ≥ 3 mg/dL)；Female patients who are pregnant or breastfeeding；The patient is participating in other drugs or device studies that may affect this study；Patient with cerebral vasculitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality
Ming Wei, 13502182903, drweiming@163.com
About this study
Official title: Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis: a Prospective, Multicentre Registry Study
The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.
Read the detailed description
The focus of this trial is to investigate the neuroprotective effects of endovascular hypothermia on the refractory disease of large vessel occlusion with underlying ICAS by performing different modes of endovascular interventions including stenting, balloon dilationand balloon dilation combined with stenting in patients who meet clinical and imaging criteria. The clinical prognosis of patients with different treatment modalities will be followed up to provide high quality clinical evidence to guide the interventional treatment of potential large vessel occlusions in ICAS. The main objectives of the study were to establish a prospective cohort of acute large vessel occlusions with potential ICAS treated with endovascular therapy based on the specific etiology of stroke with a high prevalence of intracranial atherosclerotic stenosis in the Chinese population; to explore the efficacy and safety of endovascular therapy for acute ischaemic stroke with potential ICAS; to investigate the use of different endovascular treatment modalities for acute ischaemic stroke with potential ICAS in the Chinese population; and to explore the neuroprotective effects of selective endovascular hypothermia on large vessel occlusions with potential ICAS. To explore the neuroprotective effect of selective endovascular hypothermia on large vessel occlusion in potential ICAS. To provide objective data and theoretical support for the choice of treatment for large vessel occlusion in underlying ICAS
- Conditions
- Large Vessel Occlusion, Intracranial Artery Occlusion With Cerebral Infarction, Endovascular Treatments, Acute Ischemic Stroke
- Being tested
- balloon dilatation
- Keywords
- Endovascular treatments, Acute ischemic stroke, Stroke etiology, Retrieved clots, Intracranial artery stenosis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon dilatationDevice
Also called endovascular stenting, aspiration catheter, stent retriever, Tirofiban
Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting Receives: Device: balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days
Measured: patients achieve a clinical prognosis of mRS 0-2 at 90 days
Secondary outcomes (3)
Proportion of patients with a good prognosis early after treatment
Decrease in NIHSS score ≥ 8 or NIHSS score of 0-2 in 24 (-2/+12) hours
Measured: 24 hours after thrombectomy
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR
Measured: 24 hours after thrombectomy
Vascular recanalization
Revascularisation assessed by DSA immediately after thrombectomy；Postoperative revascularisation assessed by CTA/MRA/DSA using Arterial Occlusive Lesion (AOL) grading at 24 (-2/+12) hours postoperatively；Application of bedside TCD for assessment of revascularisation
Measured: Immediately after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Vessel OcclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
- Investigators
- Ming Wei, doctorate, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260969
- Sponsor's protocol ID
- TJHH-2023-WM13
- Status last verified
- Feb 2024
- First submitted
- 30 Dec 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis: a Prospective, Multicentre Registry Study
- ClinicalTrials.gov ID
- NCT06260969
- Acronym / sponsor ID
- TJHH-2023-WM13
- Conditions
- Large Vessel Occlusion, Intracranial Artery Occlusion With Cerebral Infarction, Endovascular Treatments, Acute Ischemic Stroke
- Keywords
- Endovascular treatments, Acute ischemic stroke, Stroke etiology, Retrieved clots, Intracranial artery stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 15 Feb 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 study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.
Detailed description
The focus of this trial is to investigate the neuroprotective effects of endovascular hypothermia on the refractory disease of large vessel occlusion with underlying ICAS by performing different modes of endovascular interventions including stenting, balloon dilationand balloon dilation combined with stenting in patients who meet clinical and imaging criteria. The clinical prognosis of patients with different treatment modalities will be followed up to provide high quality clinical evidence to guide the interventional treatment of potential large vessel occlusions in ICAS. The main objectives of the study were to establish a prospective cohort of acute large vessel occlusions with potential ICAS treated with endovascular therapy based on the specific etiology of stroke with a high prevalence of intracranial atherosclerotic stenosis in the Chinese population; to explore the efficacy and safety of endovascular therapy for acute ischaemic stroke with potential ICAS; to investigate the use of different endovascular treatment modalities for acute ischaemic stroke with potential ICAS in the Chinese population; and to explore the neuroprotective effects of selective endovascular hypothermia on large vessel occlusions with potential ICAS. To explore the neuroprotective effect of selective endovascular hypothermia on large vessel occlusion in potential ICAS. To provide objective data and theoretical support for the choice of treatment for large vessel occlusion in underlying ICAS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | – | Device: balloon dilatationDirect balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute cerebral infarction with underlying intracranial artery stenosis receiving endovascular treatment
Key inclusion criteria (1 listed)
- CT scan to exclude intracranial haemorrhage；CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography showing occlusion of the distal intracranial carotid artery or the first segment of the middle cerebral artery；ELVO with a base ICAS of > 70%；Mechanical thrombectomy within 6h after symptom onset in ischemic stroke；NIHSS≥6；receiving endovascular treatments；informed consent form signed by the patient or their legal representatives.
Key exclusion criteria (1 listed)
- Hemorrhagic body, coagulation factor deficiency or oral anticoagulant therapy(INR > 3.0)；Baseline platelet count <50,000/µL；Baseline blood glucose <50mg/dL or >400mg/dL；Intractable hypertension(systolic blood pressure >220 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by medication；Patients intubated without a NIHSS score assessed by a neurologist or emergency physician prior to intubation；Stroke attack with epilepsy affecting baseline NIHSS score；End-stage diseases leading to less than one year of expected survival for patients；Severe allergy to contrast media；Patients with renal insufficiency (blood creatinine ≥ 3 mg/dL)；Female patients who are pregnant or breastfeeding；The patient is participating in other drugs or device studies that may affect this study；Patient with cerebral vasculitis
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 |
|---|---|---|
| balloon dilatationAlso: endovascular stenting, aspiration catheter, stent retriever, TirofibanDirect balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting | Device | Endovascular therapy |
Primary outcome
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days
Time frame: patients achieve a clinical prognosis of mRS 0-2 at 90 days
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days
3 secondary outcomes
Proportion of patients with a good prognosis early after treatment
Time frame: 24 hours after thrombectomy
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR
Time frame: 24 hours after thrombectomy
Vascular recanalization
Time frame: Immediately after thrombectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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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. This study is not recruiting at the moment.
Ming Wei, doctorate principal investigator
Tianjin Huanhu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large Vessel Occlusion and Intracranial Artery Occlusion With Cerebral Infarction, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Wei, 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?
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days (time frame: patients achieve a clinical prognosis of mRS 0-2 at 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 15 Feb 2024.