Stroke, IschemicVBAO-LATENCT06510634
Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion
An observational study of Stroke, Ischemic, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Endovascular Therapy
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to Mar 2028
- Phase
- Observational
- 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 90 years
- All sexes
- Adult, Older adult
Study population: This study is a prospective, multicenter cohort study, which analyzed the prospectively databases of 11 stroke centers.Including patients with ischemic stroke due to vertebrobasilar artery beyond 24 hours from last known well.
Who may be able to join
- age≥18 years.;
- blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);
- VBAO occurrence more than 24 hours from LKW;
- none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;
- informed consent before enrollment in the clinical trials.
Who cannot join
- neuroimaging evidence of cerebral hemorrhage on presentation;
- lack of follow up information on outcomes at 90 days
- serious, advanced, or terminal illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of Endovascular Treatment vs. Best Medical Treatment in Patients With Vertebrobasilar Artery Occlusion Presenting Beyond 24 Hours of Last Known Well：a Prospective, Multicenter Registry Study
Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.
- Conditions
- Stroke, Ischemic
- Being tested
- Endovascular Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TherapyOther
Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging.
Endovascular therapy includes any one or more of the following:
Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.
| Study group | Role | What they receive |
|---|---|---|
| endovascular thrombectomy group | The EVT group would include Stent retriever thrombectomy; Aspiration; Balloon angioplasty and/or stenting; Intra-arterial medication; Combination Receives: Other: Endovascular Therapy | |
| best medical treatment gruop | BMM consisted of IVT antiplatelet drugs, anticoagulation, or combinations of these treatment modalities according to institutional guidelines. Receives: Other: Endovascular Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Measured: 90(±14)days
Secondary outcomes (3)
distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Measured: 90(±14)days
Mortality within 90 days
mortality of any causes.
Measured: 90(±14)days
Incidence of symptomatic intracranial haemorrhage
Symptomatic intracranial hemorrhage was characterized as any type of intracranial hemorrhage observed on follow-up imaging between 22 and 36 hours and 7 days after stroke onset, accompanied by an increase of at least 4 points on the NIHSS from baseline or the lowest value within 7 days, or resulting in mortality.
Measured: 90(±14)days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jun 2019
- Primary completion1 Apr 2024
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 236 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
- NCT06510634
- Sponsor's protocol ID
- TJHH-2024-WM51
- Acronym
- VBAO-LATE
- Status last verified
- Feb 2025
- First submitted
- 14 Jul 2024
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Endovascular Treatment vs. Best Medical Treatment in Patients With Vertebrobasilar Artery Occlusion Presenting Beyond 24 Hours of Last Known Well：a Prospective, Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT06510634
- Acronym / sponsor ID
- VBAO-LATE / TJHH-2024-WM51
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Jul 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.
Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endovascular thrombectomy group | – | Other: Endovascular TherapyThe EVT group would include Stent retriever thrombectomy; Aspiration; Balloon angioplasty and/or stenting; Intra-arterial medication; Combination |
| best medical treatment gruop | – | Other: Endovascular TherapyBMM consisted of IVT antiplatelet drugs, anticoagulation, or combinations of these treatment modalities according to institutional guidelines. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective, multicenter cohort study, which analyzed the prospectively databases of 11 stroke centers.Including patients with ischemic stroke due to vertebrobasilar artery beyond 24 hours from last known well.
Key inclusion criteria (5 listed)
- age≥18 years.;
- blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);
- VBAO occurrence more than 24 hours from LKW;
- none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;
- informed consent before enrollment in the clinical trials.
Key exclusion criteria (3 listed)
- neuroimaging evidence of cerebral hemorrhage on presentation;
- lack of follow up information on outcomes at 90 days
- serious, advanced, or terminal illness.
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 TherapyEndovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices. | Other | best medical treatment gruop, endovascular thrombectomy group |
Primary outcome
proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days
Time frame: 90(±14)days
A 0-6 scale running from perfect health without symptoms to death.
3 secondary outcomes
distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days
Time frame: 90(±14)days
Mortality within 90 days
Time frame: 90(±14)days
Incidence of symptomatic intracranial haemorrhage
Time frame: 90(±14)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 28 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, Ischemic, 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 28 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days (time frame: 90(±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 28 Feb 2025.