Vertebrobasilar StrokeBASILAR-2NCT04743076
A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion
A study testing Endovascular treatment and Standard medical treatment in people with Vertebrobasilar Stroke, run by Xinqiao Hospital of Chongqing at 16 sites in China.
Trial summary
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebrobasilar Stroke
- What is being tested?
- Endovascular treatment and Standard medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 16 sitesChina
- Study dates
- 16 Mar 2021to 16 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age: i. 18 ~ 80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
- NIHSS score ≥ 10 before randomization;
- VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
- Time from stroke onset to randomization within 23.5 hours;
- Written informed consent is obtained from patients and/or their legal representatives.
Who cannot join
- CT or MR evidence of intracranial hemorrhage;
- Pre-morbidity with a modified Rankin scale score ≥ 3;
- The patient is in deep coma;
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
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- Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
- Imaging manifestations of diffuse bilateral brainstem ischemia;
- Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
- Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
- Participating in other clinical trials;
- Any terminal illness with life expectancy less than 6 months;
- Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Past neurological or psychiatric diseases that hinder the assessment of neurological function;
- Unlikely to be available for 90-day follow-up.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Banan District People's Hospital
Banan, Chongqing Municipality, 400040
The First Affiliated Hospital of Jilin University
Changchun, Jilin, 130000
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
The 924th Hospital of CPLA
Guilin, Guangxi, 541000
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Wuyi Traditional Chinese Medicine Hospital
Jiangmen, Guangdong, 529000
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030
Danzhai People's Hospital
Longquan, Guizhou, 557500
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Maoming Traditional Chinese Medicine Hospital
Maoming, Guangdong, 525000
Nanyang Central Hospital
Nanyang, Henan, 473000
Wuhan No. 1 Hospital
Wuhan, Hubei, 430000
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000
The 904th Hospital of CPLA
Wuxi, Jiangsu, 214000
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Chinese Medical Hospital of Zhongshan
Zhongshan, Guangdong, 528400
About this study
Official title: Standard Medical Treatment Plus Endovascular Treatment Versus Standard Medical Treatment Alone for Stroke Patient With Large Vessel Occlusion In The Posterior Circulation: A Multicenter, Randomized, Clinical Trial
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Read the detailed description
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.
The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
- Conditions
- Vertebrobasilar Stroke
- Being tested
- Endovascular treatment, Standard medical treatment
- Keywords
- endovascular treatment, thrombolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentProcedure or surgery
Endovascular treatment
Standard medical treatmentOther
Standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Standard medical treatment plus endovascular treatment Receives: Procedure: Endovascular treatment; Other: Standard medical treatment |
| Control group | Active comparator | Standard medical treatment alone Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale score
disability level
Measured: 90 days
Secondary outcomes (11)
Rate of a score of 0~2 on modified Rankin scale
Functional independence
Measured: 90 days
Improvement in NIHSS between baseline and 24 hours
neurological changes
Measured: at 24 hours from randomization
Improvement in NIHSS between baseline and 5~7d
neurological changes
Measured: at 5~7 days from randomization
Improvement in GCS between baseline and 24 hours
neurological changes
Measured: at 24 hours from randomization
Improvement in GCS between baseline and 24 hours
neurological changes
Measured: at 5~7 days from randomization
Asymptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage
Measured: within 48 hours after endovascular treatment
Procedural-related complications and severe adverse events
evaluate complications and any adverse events
Measured: within 90 days
Serious non-hemorrhagic adverse events
evaluate complications and any adverse events
Measured: within 90 days
Score of 90-day EQ-5D scale
Functional independence
Measured: 90 days
Mortality within 90 days
evaluate death rate of the two treatment groups
Measured: 90 days
Symptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage
Measured: within 48 hours after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start16 Mar 2021
- Primary completion16 May 2024 (estimated)
- Study completion16 May 2024 (estimated)
Why it stopped: Withdrawal of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebrobasilar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Qingwu Yang, MD, Principal investigator, Neurology, Xinqiao Hospital of the Army Medical UniversityWenjie Zi, MD, Principal investigator, Neurology, Xinqiao Hospital of the Army Medical UniversityRaul G Nogueira, MD, Principal investigator, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USAJeffrey L Saver, MD, Principal investigator, Neurology, University of California, Los Angeles, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743076
- Sponsor's protocol ID
- BASILAR-2
- Acronym
- BASILAR-2
- Status last verified
- Sep 2021
- First submitted
- 2 Feb 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study data without patient information
Publications
Writing Group for the BASILAR Group; Zi W, Qiu Z, Wu D, Li F, Liu H, Liu W, Huang W, Shi Z, Bai Y, Liu Z, Wang L, Yang S, Pu J, Wen C, Wang S, Zhu Q, Chen W, Yin C, Lin M, Qi L, Zhong Y, Wang Z, Wu W, Chen H, Yao X, Xiong F, Zeng G, Zhou Z, Wu Z, Wan Y, Peng H, Li B, Hu X, Wen H, Zhong W, Wang L, Jin P, Guo F, Han J, Fu X, Ai Z, Tian X, Feng X, Sun B, Huang Z, Li W, Zhou P, Tu M, Sun X, Li H, He W, Qiu T, Yuan Z, Yue C, Yang J, Luo W, Gong Z, Shuai J, Nogueira RG, Yang Q. Assessment of Endovascular Treatment for Acute Basilar Artery Occlusion via a Nationwide Prospective Registry. JAMA Neurol. 2020 May 1;77(5):561-573. doi: 10.1001/jamaneurol.2020.0156.
PubMed 32080711
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Medical Treatment Plus Endovascular Treatment Versus Standard Medical Treatment Alone for Stroke Patient With Large Vessel Occlusion In The Posterior Circulation: A Multicenter, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT04743076
- Acronym / sponsor ID
- BASILAR-2 / BASILAR-2
- Conditions
- Vertebrobasilar Stroke
- Keywords
- endovascular treatment, thrombolysis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Withdrawal of funding
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 16 May 2024 (estimated)
- Study completion
- 16 May 2024 (estimated)
- First posted
- 8 Feb 2021 (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 aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Detailed description
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.
The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Endovascular treatment, Other: Standard medical treatmentStandard medical treatment plus endovascular treatment |
| Control group | Active comparator | Other: Standard medical treatmentStandard medical treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: i. 18 ~ 80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
- NIHSS score ≥ 10 before randomization;
- VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
- Time from stroke onset to randomization within 23.5 hours;
- Written informed consent is obtained from patients and/or their legal representatives.
Key exclusion criteria (15 listed)
- CT or MR evidence of intracranial hemorrhage;
- Pre-morbidity with a modified Rankin scale score ≥ 3;
- The patient is in deep coma;
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
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 treatmentEndovascular treatment | Procedure or surgery | Intervention group |
| Standard medical treatmentStandard medical treatment | Other | Control group, Intervention group |
Primary outcome
Modified Rankin scale score
Time frame: 90 days
disability level
11 secondary outcomes
Rate of a score of 0~2 on modified Rankin scale
Time frame: 90 days
Improvement in NIHSS between baseline and 24 hours
Time frame: at 24 hours from randomization
Improvement in NIHSS between baseline and 5~7d
Time frame: at 5~7 days from randomization
Improvement in GCS between baseline and 24 hours
Time frame: at 24 hours from randomization
Improvement in GCS between baseline and 24 hours
Time frame: at 5~7 days from randomization
Asymptomatic intracranial hemorrhage within 48 hours
Time frame: within 48 hours after endovascular treatment
Procedural-related complications and severe adverse events
Time frame: within 90 days
Serious non-hemorrhagic adverse events
Time frame: within 90 days
Score of 90-day EQ-5D scale
Time frame: 90 days
Mortality within 90 days
Time frame: 90 days
Symptomatic intracranial hemorrhage within 48 hours
Time frame: within 48 hours after endovascular treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 32080711Writing Group for the BASILAR Group; Zi W, Qiu Z, Wu D, Li F, Liu H, Liu W, Huang W, Shi Z, Bai Y, Liu Z, Wang L, Yang S, Pu J, Wen C, Wang S, Zhu Q, Chen W, Yin C, Lin M, Qi L, Zhong Y, Wang Z, Wu W, Chen H, Yao X, Xiong F, Zeng G, Zhou Z, Wu Z, Wan Y, Peng H, Li B, Hu X, Wen H, Zhong W, Wang L, Jin P, Guo F, Han J, Fu X, Ai Z, Tian X, Feng X, Sun B, Huang Z, Li W, Zhou P, Tu M, Sun X, Li H, He W, Qiu T, Yuan Z, Yue C, Yang J, Luo W, Gong Z, Shuai J, Nogueira RG, Yang Q. Assessment of Endovascular Treatment for Acute Basilar Artery Occlusion via a Nationwide Prospective Registry. JAMA Neurol. 2020 May 1;77(5):561-573. doi: 10.1001/jamaneurol.2020.0156.
- Individual participant dataSharing planned: Yes. study data without patient information
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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.
Qingwu Yang, MD principal investigator
Neurology, Xinqiao Hospital of the Army Medical University
Wenjie Zi, MD principal investigator
Neurology, Xinqiao Hospital of the Army Medical University
Raul G Nogueira, MD principal investigator
Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment and Standard medical treatment in people with Vertebrobasilar Stroke, run by Xinqiao Hospital of Chongqing at 16 sites 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 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: paused, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
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?
Modified Rankin scale score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743076, which also lists 1 linked publication.
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 14 Sep 2021.