NCT05827042 Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion
| NCT ID | NCT05827042 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The First Affiliated Hospital of University of Science and Technology of China |
| Condition | Basilar Artery Occlusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 338 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 338 participants in total. It began in 2023-05-09 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery; 2. Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion; 3. Patient's age ≥ 18 years; 4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery; 5. Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria; 6. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10; 7. The patient or patient's legal representative signs the informed consent form. Exclusion Criteria: 1. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed); 2. Pre-stroke modified Rankin scale (mRS) score ≥ 2; 3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) \<5; 4. Pregnant or lactating women; 5. Allergy to contrast agent or nitinol alloy; 6. Life expectancy\<1 year; 7. CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment; 8. Participating in other clinical trials; 9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which can not be controlled by antihypertensive drugs; 10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) \> 1.7; or novel oral anticoagulant within prior 48 hours; 11. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L; 12. Renal insufficiency defined as serum creatinine \>2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate \<30 mL/min, need for hemodialysis or peritoneal dialysis; 13. Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc); 14. The patient has acute ischemic cerebral infarction within 3 months from randomization; 15. The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis; 16. The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition; 17. CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle; 18. Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination; 19. CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion; 20. Patients with intracranial tumors (except small meningiomas); 21. Patients who received intravenous thrombolytics treatment before the randomization.
Contact & Investigator
Wei Hu, MD
STUDY CHAIR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT05827042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Basilar Artery Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05827042 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 338 participants.
Is NCT05827042 currently recruiting?
Yes, NCT05827042 is actively recruiting participants. Contact the research team at andinghu@ustc.edu.cn for enrollment information.
Where is the NCT05827042 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT05827042 clinical trial?
NCT05827042 is sponsored by The First Affiliated Hospital of University of Science and Technology of China. The principal investigator is Wei Hu, MD at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 338 participants.