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Procedure

Rescue Thrombectomy for Stroke (2BE3 Trial)

N/A

Waitlist Available

Led By Daniela Iancu, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at end of procedure

Awards & highlights

2BE3 Trial Summary

This trial will study if rescue therapies can improve outcomes in stroke patients with large proximal vessel occlusion.

Who is the study for?

This trial is for stroke patients who've had a clot removed from a large brain artery but still have smaller blockages. They must be candidates for thrombectomy, not at high risk of bleeding or poor prognosis due to other illnesses, and not on certain blood thinners.Check my eligibility

What is being tested?

The study compares standard mechanical thrombectomy (clot removal) with an added 'rescue' treatment for remaining small clots in the brain. Patients are randomly chosen to receive either just the standard care or additional mechanical/pharmacological interventions.See study design

What are the potential side effects?

Potential side effects may include risks associated with additional invasive procedures such as bleeding, possible vessel damage during rescue thrombectomy, and allergic reactions or complications from intra-arterial drugs.

2BE3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a blockage in a major brain artery and am eligible for clot removal.

2BE3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Mortality rate

Number of thrombectomy passes

+10 more

2BE3 Trial Design

2Treatment groups

Active Control

Group I: Conservative managementActive Control1 Intervention

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

Group II: Rescue therapyActive Control2 Interventions

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,337 Total Patients Enrolled

Daniela Iancu, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

2 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this experiment?

"The information hosted on clinicaltrials.gov indicates that patient recruitment has ceased for this trial, which was originally posted in January 1st 2024 and last updated September 11th 2023. Despite the current inactive status of this medical study, there are a wealth of other trials actively recruiting at present with 1119 studies currently listed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy

2024. "Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034847.