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Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
In stroke patients, mechanical thrombectomy is now the standard of care when the stroke is due to large proximal cerebral vessel occlusion. The purpose of the 2BE3 trial is to test whether adjunct rescue treatment of persisting distal occlusions after successful proximal recanalization of the large vessel occlusion can be proposed as an additional intervention to restore reperfusion of affected stroke tissue and improve clinical outcomes. The rescue therapies will be either mechanical (small stent retrievers and/or small aspiration catheters) or pharmacological (infusion of intra-arterial thrombolytics). Patients will be randomized to conservative management (mechanical thrombectomy with or without IV thrombolytics of large proximal vessels) or rescue therapy (mechanical or pharmacological interventions in distal vessels in addition to conservative management). Each patient will be followed for 3 months post-intervention. The data collected will be clinical assessments and angiographic imaging to evaluate the reperfusion state.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-09
Completion Date
2029-01
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
Mechanical thrombectomy in proximal large vessels
mechanical thrombectomy with retrievable stents to remove clots in proximal large vessels, combined or not with distal aspiration, combined or not with IV thrombolytics
Rescue mechanical thrombectomy in distal vessels
In addition to mechanical thrombectomy in proximal large vessels, mechanical thrombectomy in distal vessels with small stent retrievers combined or not with contact aspiration, or intra-arterial perfusion of thrombolytics such as tPA or uPA or tenecpeplase
Locations (1)
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada