Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy

NCT06034847 | Withdrawn DMC

• 1 other identifier: 2024-11741
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Acute Thrombotic

Keywords

Large vessel occlusion; Persistent distal occlusion; Mechanical thrombectomy; Intra-arterial thrombolytics

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Secondary Outcomes (13)

• score on the modified Rankin Scale. The modified Rankin score goes from 0 (no symptoms) to 6 (death). Higher scores mean a worse outcome

  90 days

• Rate of functional independence

  90 days

• Change in NIHSS (National Institutes of Health Stroke Score) score. The scale goes from 0 to 42; higher scores indicated worse outcomes.

  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.

  24 hours

• Rate of improved global ipsilateral hemispheric reperfusion

  at end of procedure

Study Arms (2)

Conservative management

ACTIVE COMPARATOR

Mechanical thrombectomy of large vessel occlusions with or without administration of IV thrombolytics

Device: Mechanical thrombectomy in proximal large vessels

Rescue therapy

ACTIVE COMPARATOR

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

Interventions

Mechanical thrombectomy in proximal large vessels DEVICE

mechanical thrombectomy with retrievable stents to remove clots in proximal large vessels, combined or not with distal aspiration, combined or not with IV thrombolytics

Conservative management; Rescue therapy

Rescue mechanical thrombectomy in distal vessels DEVICE

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

Rescue therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient with a large vessel occlusion in the M1 or M2 segment of the MCA (Middle Cerebral Artery), supraclinoid ICA (Internal Carotid Artery), or basilar artery who is a candidate for thrombectomy
• with a persistent distal occlusion in M2-M4, A1-A5, P1-P5 after successful recanalization of the proximal clot with mechanical thrombectomy and/or IV thrombolysis

You may not qualify if:

• poor 3 month prognosis from comorbidities
• evidence of active bleeding on examination
• recent surgery with a significant risk of bleeding
• VKA (Vitamin K Antagonists) oral anticoagulation with INR (International Normalized Ratio) - \> 1.7
• curative heparin or direct oral anticoagulants in previous 48 hours
• platelet count \< 100 000/mm3

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Thrombotic Stroke

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniela Iancu, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2024
• Primary Completion: November 5, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)