An interventional study of Mechanical thrombectomy in proximal large vessels and Rescue mechanical thrombectomy in distal vessels in Stroke, Acute Thrombotic, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
The purpose of the 2BE3 trial is to provide a clinical trial context for the use of rescue therapy (mechanical or pharmacological therapies) in patients with persistent distal occlusions after treatment of large vessel occlusions with mechanical thrombectomy and IV thrombolytics. The main hypothesis is that rescue therapy with mechanical or pharmacological therapies, compared with conservative management would result in improved clinical and reperfusion scores at 90 days.
The extent of reperfusion is an interesting therapeutic target because reperfusion status is a strong indicator of clinical outcome: grades of better reperfusion are incrementally associated with better clinical outcomes. Despite increased expertise of neuro-interventional teams and the evolution in thrombectomy devices, incomplete reperfusion occurs in almost half of patients undergoing treatment of large vessel occlusions. Thus, complementary treatments targeting distal occlusions and known as "rescue therapy" have been introduced to reach complete or near complete reperfusion.
The devices and techniques proposed as rescue therapies include small stent retrievers, small aspiration catheters and intra-arterial thrombolytics. Case studies and registries have shown high reperfusion rates and low rates of periprocedural complications; however, there is lack of randomized data to show the impact of rescue therapies on patient outcomes and safety compared to conservative management (treatment of large vessel occlusions only). A randomized clinical trial is therefore needed.
The 2BE3 trial is a simple randomized trial designed to be integrated into daily clinical practice. It will address whether rescue therapies truly offer a safe and more effective alternative to conservative management. Selection criteria are loose in order to be of use to most patients. Endpoints are simple, clinical, meaningful, valuable and resistant to bias. It includes no extra risk or cost of visits beyond what is required in routine care.
The design is multicenter, prospective, randomized, controlled, open-label study with blinded evaluation (PROBE design). The study population is acute ischemic stroke patients with persistent distal occlusions after treatment of large vessel occlusion with mechanical thrombectomy and/or intravenous thrombolysis. The total number of patients will be 300, 150 in each arm, each followed for 3 months post-intervention.
21 studies on the registry are indexed under Thrombotic Stroke; 8 are open to participants now.
Browse Thrombotic Stroke studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mechanical thrombectomy of large vessel occlusions with or without administration of IV thrombolytics
Device: Mechanical thrombectomy in proximal large vessels
In addition to conservative management, rescue therapy in distal occlusions consisting of either mechanical thrombectomy with small stent retrievers with or without contact aspiration, or intra-arterial pharmacotherapy with tPA (tissue Plasminogen Activator), uPA (urokinase Plasminogen Activator) or tenecteplase.
Device: Mechanical thrombectomy in proximal large vessels · Device: Rescue mechanical thrombectomy in distal 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
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
Rate of modified Rankin Scale score of 0-2. The modified Rankin score goes from 0 (no symptoms) to 6 (death). Higher scores mean a worse outcome
proportion of patients with a modified Rankin Scale score of 0-2
Time frame: 90 days
score on the modified Rankin Scale. The modified Rankin score goes from 0 (no symptoms) to 6 (death). Higher scores mean a worse outcome
score on the modified Rankin Scale
Time frame: 90 days
Rate of functional independence
Functional independence is defined as a modified Rankin Scale score of 0-2
Time frame: 90 days
Change in NIHSS (National Institutes of Health Stroke Score) score. The scale goes from 0 to 42; higher scores indicated worse outcomes.
Difference between the NIHSS score at Registration and at 24 hours post-intervention
Time frame: 24 hours
Rate of NIHSS (National Institutes of Health Stroke Score) score improvement. The scale goes from 0 to 42; higher scores indicated worse outcomes.
Rate of decrease of 4 points or more in NIHSS score
Time frame: 24 hours
Rate of improved global ipsilateral hemispheric reperfusion
blinded assessment of reperfusion on angiogram as measured by the modified TICI (Thrombolysis in Cerebral Infarction) scale. The scale goes from 0 to 3; higher scores indicate better outcomes
Time frame: at end of procedure
Rate of reperfusion
assessed by the modified TICI (Thrombolysis in Cerebral Infarction) scale on angiogram. The scale goes from 0 to 3; higher scores indicate better outcomes
Time frame: at end of procedure
Rate of complete reperfusion
a modified TICI (Thrombolysis in Cerebral Infarction) score of 3 on angiogram. The scale goes from 0 to 3; higher scores indicate better outcomes
Time frame: at end of procedure
Procedure time
elapsed time from arterial puncture to last angiogram
Time frame: at end of procedure
Number of thrombectomy passes
Number of thrombectomy passes to achieve final reperfusion
Time frame: at end of procedure
Mortality rate
Rate of mortality
Time frame: 24 hours and 90 days
Rate of procedural complications
defined as: vascular perforation, arterial dissection, new territory emboli, access site complication requiring surgical repair, subarachnoid hemorrhage
Time frame: at end of procedure
Rate of symptomatic intracerebral hemorrhage
hemorrhage on CT or MRI according to the Heidelberg classification associated with a 4 point or greater worsening on the NIHSS score. The Heidelberg classification goes from 1 to 3d; higher scores indicate worse outcomes.
Time frame: 24 hours
Rate of any intracranial hemorrhage
hemorrhage on CT or MRI according to the Heidelberg classification. The Heidelberg classification goes from 1 to 3d; higher scores indicate worse outcomes.
Time frame: 24 hours
Plan to share: No — there is no plan to share individual participant data
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Nov 2025, 14 months later.
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This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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