Vertebrobasilar Stroke Clinical Trial
— BASILAR-2Official 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
| NCT number | NCT04743076 |
| Other study ID # | BASILAR-2 |
| Secondary ID | |
| Status | Suspended |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 16, 2021 |
| Est. completion date | May 16, 2024 |
| Verified date | September 2021 |
| Source | Xinqiao Hospital of Chongqing |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 386 |
| Est. completion date | May 16, 2024 |
| Est. primary completion date | May 16, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Age: i. 18 ~ 80 years old, pc-ASPECTS score = 6; ii. > 80 years old, pc-ASPECTS score = 8 and mRS = 0 before the onset 2. NIHSS score = 10 before randomization; 3. VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA; 4. Time from stroke onset to randomization within 23.5 hours; 5. Written informed consent is obtained from patients and/or their legal representatives. Exclusion Criteria: 1. CT or MR evidence of intracranial hemorrhage; 2. Pre-morbidity with a modified Rankin scale score = 3; 3. The patient is in deep coma; 4. Currently in pregnant or lactating or serum beta HCG test is positive on admission; 5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 6. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys; 7. Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging; 8. Imaging manifestations of diffuse bilateral brainstem ischemia; 9. Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion); 10. Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect; 11. Participating in other clinical trials; 12. Any terminal illness with life expectancy less than 6 months; 13. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 14. Past neurological or psychiatric diseases that hinder the assessment of neurological function; 15. Unlikely to be available for 90-day follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| China | Banan District People's Hospital | Banan | Chongqing |
| China | The First Affiliated Hospital of Jilin University | Changchun | Jilin |
| China | Xinqiao Hospital of Army Medical University | Chongqing | Chongqing |
| China | Danzhai People's Hospital | Danzhai | Guizhou |
| China | The 924th Hospital of CPLA | Guilin | Guangxi |
| China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | Jiangmen Central Hospital | Jiangmen | Guangdong |
| China | Wuyi Traditional Chinese Medicine Hospital | Jiangmen | Guangdong |
| China | The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan |
| China | Maoming Traditional Chinese Medicine Hospital | Maoming | Guangdong |
| China | Nanyang Central Hospital | Nanyang | Henan |
| China | Wuhan No. 1 Hospital | Wuhan | Hubei |
| China | Yijishan Hospital of Wannan Medical College | Wuhu | Anhui |
| China | The 904th Hospital of CPLA | Wuxi | Jiangsu |
| China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
| China | Chinese Medical Hospital of Zhongshan | Zhongshan | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Xinqiao Hospital of Chongqing |
China,
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, P — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Modified Rankin scale score | disability level | 90 days | |
| Secondary | Rate of a score of 0~2 on modified Rankin scale | Functional independence | 90 days | |
| Secondary | Improvement in NIHSS between baseline and 24 hours | neurological changes | at 24 hours from randomization | |
| Secondary | Improvement in NIHSS between baseline and 5~7d | neurological changes | at 5~7 days from randomization | |
| Secondary | Improvement in GCS between baseline and 24 hours | neurological changes | at 24 hours from randomization | |
| Secondary | Improvement in GCS between baseline and 24 hours | neurological changes | at 5~7 days from randomization | |
| Secondary | Asymptomatic intracranial hemorrhage within 48 hours | evaluate intracranial hemorrhage | within 48 hours after endovascular treatment | |
| Secondary | Procedural-related complications and severe adverse events | evaluate complications and any adverse events | within 90 days | |
| Secondary | Serious non-hemorrhagic adverse events | evaluate complications and any adverse events | within 90 days | |
| Secondary | Score of 90-day EQ-5D scale | Functional independence | 90 days | |
| Secondary | Mortality within 90 days | evaluate death rate of the two treatment groups | 90 days | |
| Secondary | Symptomatic intracranial hemorrhage within 48 hours | evaluate intracranial hemorrhage | within 48 hours after endovascular treatment |