Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

NCT ID: NCT05827042

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2026-03-31

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.

Detailed Description

Two recent randomized, controlled trials from China-ATTENTION (Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion) and BAOCHE (Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The DEVT (Direct Endovascular Treatment versus Standard Bridging Therapy for Acute Stroke Patients with Large Vessel Occlusion in The Anterior Circulation) and DIRECT-MT (Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Trial) trials showed that endovascular thrombectomy alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. However, it is unclear whether endovascular thrombectomy alone is noninferior to intravenous thrombolysis bridging with endovascular thrombectomy for achieving functional independence at 90 days among patients with acute basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of endovascular thrombectomy alone in these patients.

Conditions

Basilar Artery Occlusion; Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endovascular thrombectomy alone

Patients will receive endovascular thrombectomy without intravenous thrombolysis.

Group Type: EXPERIMENTAL

Endovascular thrombectomy

Intervention Type: PROCEDURE

Endovascular thrombectomy

Intravenous thrombolysis plus endovascular thrombectomy

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Group Type: ACTIVE_COMPARATOR

Intravenous thrombolysis

Intervention Type: DRUG

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Endovascular thrombectomy

Intervention Type: PROCEDURE

Endovascular thrombectomy

Interventions

Intravenous thrombolysis

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Intervention Type: DRUG

Endovascular thrombectomy

Endovascular thrombectomy

Intervention Type: PROCEDURE

Other Intervention Names

Alteplase or Tenecteplase

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of University of Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Hu, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of University of Science and Technology of China

Locations

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Hu, MD

Role: CONTACT

andinghu@ustc.edu.cn

+8615155510611

Facility Contacts

Wei Hu, MD

Role: primary

andinghu@ustc.edu.cn

+8615155510611

Other Identifiers

ATTENTION IV

Identifier Type: -

Identifier Source: org_study_id