Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02441556
• Date of registration: 16/04/2015
• Prospective Registration: No
• Primary sponsor: Xinfeng Liu
• Public title: Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment BEST
• Scientific title: Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
• Date of first enrolment: January 2015
• Target sample size: 131
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02441556
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Xinfeng Liu, Doctor
• Affiliation: Departmnet of Neurology, Jinling Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 years;

2. Acute ischemic stroke consistent with infarction in the basilar artery territory;

3. Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated
occlusion time;

4. Written informed consent from patient or surrogate, if unable to provide consent.

Exclusion Criteria:

1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral
hemorrhage on presentation;

2. Premorbid mRS = 3 points;

3. Currently in pregnant or lactating;

4. Known serious sensitivity to radiographic contrast agents and nitinol metal;

5. Current participation in another investigation drug or device study;

6. Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic
blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral
antihypertensive medication;

7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or
oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin
time;

8. Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or
Hct<25%;

9. Arterial tortuosity that would prevent the device from reaching the target vessel;

10. Life expectancy less than 1 year;

11. History of major hemorrhage in the past 6 months;

12. Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.

13. Angiographic evidence of bilateral extended brainstem ischemia.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke Due to Basilar Artery Occlusion

Acute Cerebrovascular Accidents

Intervention(s)

Device: endovascular treatment

Other: standard medical therapy

Primary Outcome(s)

modified Rankin Scale (mRS) [Time Frame: at 90 days from randomization]

Secondary Outcome(s)

EuroQol 5D (EQ-5D) [Time Frame: at 90 days from randomization]

NIHSS score [Time Frame: at 24 hours from randomization]

NIHSS score [Time Frame: at 5-7 days from randomization]

severity of procedure and device related complications [Time Frame: within 90 days from randomization]

mortality [Time Frame: at 3 months from randomization]

severity of non-intracerebral hemorrhage complications [Time Frame: within 90 days from randomization]

mRS score 0-2 [Time Frame: at 90 days from randomization]

GCS score [Time Frame: at 24 hours from randomization]

incidence of non-intracerebral hemorrhage complications [Time Frame: at 90 days from randomization]

incidence of procedure and device related complications [Time Frame: within 90 days from randomization]

symptomatic intracerebral hemorrhage (ICH) [Time Frame: within 24 hours from randomization]

Change of mRS score(shift analysis) [Time Frame: at 90 days from randomization]

GCS score [Time Frame: at 5-7 days from randomization]

incidence of nonbleeding severe adverse events (SAEs) [Time Frame: within 90 days from randomization]

Vessel recanalization rate evaluated by CT angiography or MRA [Time Frame: at 24 hours from randomization]

PC-ASPECT score on CT/MRI [Time Frame: at 24 hours from randomization]

severity of nonbleeding severe adverse events (SAEs) [Time Frame: within 90 days from randomization]

Secondary ID(s)

JLH-NEURO-2015-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors