Rescue Thrombectomy for Stroke
(2BE3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if additional treatment can aid stroke patients with a blockage in a smaller blood vessel after clearing the main blockage. It will compare two approaches: extra mechanical methods (such as tiny devices to remove clots, known as rescue mechanical thrombectomy in distal vessels) or medication delivered directly to the blockage, against standard care. This trial targets individuals who have experienced a stroke due to a large blood vessel blockage and still have smaller blockages in the brain after initial treatment. Researchers will monitor participants for three months to assess blood flow improvement and its impact on recovery. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery treatments.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have taken certain blood thinners like heparin or direct oral anticoagulants in the previous 48 hours. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mechanical thrombectomy for blockages in smaller blood vessels is generally safe and feasible. One study found that this procedure can lead to successful results, though it carries some risk. Specifically, there is a higher chance of bleeding in the brain (symptomatic intracranial hemorrhage) compared to not having the procedure.
In contrast, testing small devices like stent retrievers and suction catheters in this context showed that about 32% of patients had good outcomes three months later, experiencing little to no disability.
Overall, despite some risks, particularly related to bleeding, these procedures have helped many people recover better after a stroke. Potential trial participants should weigh these risks against the possible benefits.12345Why are researchers excited about this trial?
Researchers are excited about the rescue therapy for stroke because it offers a targeted approach for distal occlusions, which standard treatments may not address as effectively. Unlike typical mechanical thrombectomy that focuses on large vessel occlusions, this therapy uses small stent retrievers and can incorporate contact aspiration or intra-arterial pharmacotherapy with agents like tPA, uPA, or tenecteplase. This means it has the potential to be more effective in clearing blockages in smaller, more distal vessels, which can be crucial for improving patient outcomes in complex stroke cases.
What evidence suggests that this trial's treatments could be effective for stroke?
In this trial, participants will join different treatment arms to evaluate the effectiveness of various interventions for stroke. One arm involves rescue therapy, including mechanical thrombectomy in distal vessels. Research has shown that mechanical thrombectomy to remove clots in smaller blood vessels can aid recovery in some stroke patients. Specifically, one study reported that 32.2% of patients experienced a good recovery 90 days after the treatment. However, other studies found that while this procedure can benefit some, it doesn't always improve recovery or reduce the risk of death, and it carries risks such as increased chances of brain bleeding.
Another arm in this trial involves conservative management, which includes mechanical thrombectomy of large vessel occlusions with or without IV thrombolytics. For drug treatments, medications like tPA, which dissolve clots, are considered helpful for smaller vessels, but the exact effectiveness in these cases remains unclear from current data.14567Who Is on the Research Team?
Daniela Iancu, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either conservative management or rescue therapy for distal occlusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mechanical thrombectomy in proximal large vessels
- Rescue mechanical thrombectomy in distal vessels
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor