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Compares treatment options for Basilar Artery Occlusion
Official title Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion
ClinicalTrials.gov ID: NCT05827042
What this study is testing
What is Intravenous thrombolysis?
Intravenous thrombolysis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for basilar artery occlusion.
Also referred to as Alteplase or Tenecteplase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent...
- Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;
- Patient's age ≥ 18 years;
- Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography...
- Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard...
You likely can't join if
- CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
- Pre-stroke modified Rankin scale (mRS) score ≥ 2;
- Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance...
- Pregnant or lactating women;
- Allergy to contrast agent or nitinol alloy;
- Life expectancy\<1 year;
See the full eligibility criteria
- 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;
- Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion;
- Patient's age ≥ 18 years;
- 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...
- Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;
- The patient or patient's legal representative signs the informed consent form.
- CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
- Pre-stroke modified Rankin scale (mRS) score ≥ 2;
- 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;
- Pregnant or lactating women;
- Allergy to contrast agent or nitinol alloy;
- Life expectancy\<1 year;
- CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment;
- Participating in other clinical trials;
- Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which can not be controlled by antihypertensive drugs;
- 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;
- Blood glucose \ 400 mg/dl (22.2 mmol/L), platelet\< 100\ 109/L;
- 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;
- Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
- The patient has acute ischemic cerebral infarction within 3 months from randomization;
- The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
- The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;
- CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
- Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
- CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
- Patients with intracranial tumors (except small meningiomas);
- Patients who received intravenous thrombolytics treatment before the randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.