300 Participants Needed

Rescue Thrombectomy for Stroke

(2BE3 Trial)

DI
GG
Overseen ByGuylaine Gevry, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 mechanical thrombectomy generally safe for humans?

Mechanical thrombectomy is generally considered safe for treating strokes, but there is an increased risk of some complications like recurrent strokes, bleeding in the brain (subarachnoid hemorrhage), and blood vessel spasms (vasospasms). Careful monitoring is recommended after the procedure.12345

How is mechanical thrombectomy unique compared to other stroke treatments?

Mechanical thrombectomy is unique because it physically removes the blood clot from a large vessel in the brain, which can significantly improve outcomes for stroke patients. Unlike other treatments that may use medication to dissolve clots, this procedure directly retrieves the clot, making it effective even when medication alone is insufficient.678910

What data supports the effectiveness of the treatment Rescue Thrombectomy for Stroke?

Research shows that mechanical thrombectomy, a procedure to remove blood clots from large vessels, significantly improves outcomes in stroke patients. Additionally, using rescue devices can increase the success rate of restoring blood flow, especially in certain areas of the brain.611121314

Who Is on the Research Team?

DI

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

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

Exclusion Criteria

I recently had surgery that could cause serious bleeding.
You have other health issues that may make it unlikely for you to live for another 3 months.
Your platelet count is less than 100,000 per cubic millimeter.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conservative management or rescue therapy for distal occlusions

Immediate intervention
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Routine follow-up visits as per standard care

What Are the Treatments Tested in This Trial?

Interventions

  • Mechanical thrombectomy in proximal large vessels
  • Rescue mechanical thrombectomy in distal vessels
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Rescue therapyActive Control2 Interventions
Group II: Conservative managementActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Published Research Related to This Trial

Mechanical thrombectomy (MT) is safe and effective for treating acute stroke patients with emergent large vessel occlusion (ELVO) even when they have a high international-normalized ratio (INR) greater than 1.7, as shown in a study of 315 patients.
The study found no significant differences in rates of symptomatic intracranial hemorrhage, 3-month mortality, successful reperfusion, or functional independence between patients with high INR and those with normal INR, indicating that high INR does not adversely affect MT outcomes.
Mechanical thrombectomy outcomes in large vessel stroke with high international normalized ratio.Pandhi, A., Tsivgoulis, G., Ishfaq, MF., et al.[2019]

Citations

Mechanical thrombectomy via chronic occluded proximal artery for the endovascular treatment of acute ischemic stroke patients with large vessel occlusion. [2022]
Mechanical Thrombectomy Using Retrievable Stents in Pediatric Acute Ischemic Stroke. [2020]
Added Value of Rescue Devices in Intra-Arterial Thrombectomy: When Should We Apply Them? [2021]
Bail-out intracranial stenting with Solitaire AB device after unsuccessful thrombectomy in acute ischemic stroke of anterior circulation. [2019]
Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis. [2022]
Mechanical thrombectomy outcomes in large vessel stroke with high international normalized ratio. [2019]
Mechanical thrombectomy in patients with proximal occlusions and low NIHSS: Results from a large prospective registry. [2020]
Thrombectomy for ischemic stroke: meta-analyses of recurrent strokes, vasospasms, and subarachnoid hemorrhages. [2022]
Mechanical thrombectomy for emergent large vessel occlusion: a critical appraisal of recent randomized controlled clinical trials. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Mechanical thrombectomy versus medical care alone in large ischemic core: An up-to-date meta-analysis. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
The Chemical Optimization of Cerebral Embolectomy trial: Study protocol. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
In vitro testing of a funnel-tip catheter with different clot types to decrease clot migration in mechanical thrombectomy. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Thrombectomy for Acute Ischemic Stroke: Recent Insights and Future Directions. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Endovascular Treatment of Acute Stroke. [2022]
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