BASICS trial: Study research to evaluate the efficacy of additional intra-arterial therapy after intravenous thrombolysis in terms of favourable outcome in patients with an acute ischemic stroke caused by basilar artery occlusion.

Conditions: The acute basilar artery occlusion (BAO) is associated with a rate of death or disability of almost 80%. Recently a prospective registry of patients with an acute BAO showed that the outcomes of patients treated with intravenous (IVT) or intra-arterial thrombolysis (IAT) were similar, underscoring the lack of a proven treatment modality in acute symptomatic BAO. This was a non-randomised study, hampered by the lack of a standard treatment protocol for all patients who entered the study
MedDRA version: 14.1Level: PTClassification code 10004163Term: Basilar artery stenosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-023507-95-IT

Lead Sponsor: St. Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 750

Inclusion Criteria

- Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS = 10 at time of randomization. - Basilar artery occlusion confirmed by CTA or MRA. - Age18 through 85 years - Initiation of IV rt-PA within 4.5 hours of estimated time of basilar artery occlusion.(Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms). - Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

• Pre-existing dependency with mRankin =3. • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission. • Patients who require hemodialysis or peritoneal dialysis. • Other serious, advanced, or terminal illness. • Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated. • Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days). • Informed consent is not or cannot be obtained. • Lesion consistent with hemorrhage of any degree. • Significant cerebellar mass effect or acute hydrocephalus. • Bilateral extended brainstem ischemia.