Basilar Artery International Cooperation Study (BASICS)
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial treatment (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of additional IAT after IVT in patients with basilar artery occlusion.
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial
Study population: Patients, aged 18 through 85 years, with CTA or MRA confirmed basilar occlusion treated with IVT.
Target number of participants: 750.
Intervention: Patients will be randomised between additional IAT followed by maximum supportive care versus maximum supportive care alone. IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IAT within 6 hours.
Main study parameters/endpoints: Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Basilar Artery Thrombosis
Basilar Artery Embolism
Stroke of Basilar Artery
Other: Intra-arterial treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Basilar Artery International Cooperation Study|
- Favourable outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
- Excellent outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
- Modified Rankin Score [ Time Frame: day 90 ] [ Designated as safety issue: No ]Modified Rankin Score - not dichotomized.
- NIHSS [ Time Frame: pre IVT, pre randomization, 24h post treatment ] [ Designated as safety issue: No ]
National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:
- directly pre intravenous thrombolysis
- directly pre randomization (post intravenous thrombolysis)
- at 24 hours +- 6 hours post treatment.
- EQ-5D [ Time Frame: day 90 and 12 months ] [ Designated as safety issue: No ]EQ-5D (quality of life) at day 90 and at 12 months.
- Recanalization [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]Recanalization at 24 hours ± 6 hours, by CT angiography.
- Volume of cerebral infarction [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]Volume of cerebral infarction on NCCT and CTA source images.
- SICH [ Time Frame: 24 hours ± 6 hours. ] [ Designated as safety issue: Yes ]Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
- Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Mortality at 90 days.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
No Intervention: No additional intra-arterial treatment.
Intravenous thrombolysis followed by maximum supportive care.
Experimental: Additional intra-arterial treatment.
Intravenous thrombolysis followed by intra-arterial treatment and maximum supportive care.
Other: Intra-arterial treatment
The choice of the IA strategy will be made by the treating neurointerventionalist. IA treatment options available will be any of the following devices or thrombolytics, depending on local approval and experience; the Merci and Trevo thrombus-removal devices, Penumbra, Solitaire, infusion of rt-PA combined with an application of low-intensity ultrasound at the site of the occlusion via the EKOS Micro-Infusion Catheter, infusion of alteplase or urokinase via a standard micro-catheter. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis.
|Contact: Wouter Schonewille, MD||+31 6 email@example.com|
|Contact: Erik van der Hoeven, MD||+31 6 firstname.lastname@example.org|
|University Hospital Modena||Recruiting|
|Modena, Italy, 41100|
|Principal Investigator: Andrea Zini, PhD|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Principal Investigator: Jeanette Hofmeijer, PhD|
|Academic Hospital Maastricht||Recruiting|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Principal Investigator: Julie Staals, PhD|
|St. Elisabeth Hospital||Recruiting|
|Tilburg, Noord Brabant, Netherlands, 5022 GC|
|Principal Investigator: Paul de Kort, PhD|
|St. Antonius Hospital||Recruiting|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Principal Investigator: Wouter Schonewille, MD|
|The Hague, Zuid-Holland, Netherlands, 2512 VA|
|Principal Investigator: Jelis Boiten, PhD|
|Universitary Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator: Jaap Kappelle, Prof.|
|University Hospital of Lausanne||Recruiting|
|Lausanne, Vaud, Switzerland, CH-1011|
|Principal Investigator: Patrik Michel, PhD|
|Principal Investigator:||W J Schonewille, MD||St. Antonius Hospital Nieuwegein|