Basilar Artery International Cooperation Study

Phase 1

• Conditions: Basilar artery occlusion; MedDRA version: 20.0 Level: PT Classification code 10063093 Term: Basilar artery thrombosis System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: PT Classification code 10048963 Term: Basilar artery occlusion System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2010-023507-95-DE
• Lead Sponsor: BASICS Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

• Symptoms and signs compatible with ischemia in the basilar artery territory.
• Basilar artery occlusion confirmed by CTA or MRA.
• Age18 or older (i.e., candidates must have had their 18th birthday).
• If IVT is considered as part of BMM, IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion.
• Initiation of IA therapy should be feasible within 6 hours of estimated time of BAO.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

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.

Imaging Exclusion Criteria
• Lesion consistent with hemorrhage of any degree.
• Significant cerebellar mass effect or acute hydrocephalus.
• Bilateral extended brainstem ischemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified