Rescue Distal Thrombectomy for Stroke

(2BE3-PhaseII Trial)

GG
Overseen ByGuylaine Gevry, BSc. Project manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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?

This trial aims to determine if an additional procedure, rescue distal mechanical thrombectomy (a type of surgical procedure), can benefit people with small blocked arteries remaining after clearing a main artery during stroke treatment. It will compare two methods: performing this extra procedure or not taking additional action after the main treatment. The trial seeks to establish whether the additional procedure is safe and beneficial for better recovery and blood flow. People with a recent stroke, who have undergone the main treatment but still have small artery blockages, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance stroke recovery treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that rescue distal mechanical thrombectomy is safe for stroke patients?

Research has shown that rescue distal mechanical thrombectomy, used after removing a main clot in stroke patients, is generally safe. One study found that this procedure, part of endovascular thrombectomy, reduced the risk of death within three months by 17% for patients with large vessel blockages. Another study noted that a similar procedure, rescue stent placement, carries a low risk of causing serious bleeding.

These findings suggest that rescue distal thrombectomy is well-tolerated and has a low risk of serious complications. However, all medical procedures carry some risk. Consulting healthcare providers can help clarify the risks and benefits specific to each situation.12345

Why are researchers excited about this trial?

Researchers are excited about rescue distal thrombectomy because it offers a potential breakthrough for treating acute ischemic stroke with persistent distal occlusions. Unlike the standard treatment, which typically involves only proximal mechanical thrombectomy followed by conservative management, this approach targets the smaller, distal blood clots that remain. By addressing these smaller clots during the same procedure, the technique aims to improve overall blood flow to the brain, potentially leading to better recovery outcomes. This method could fill a critical gap in stroke care, providing an additional layer of intervention for those with complex vascular blockages.

What evidence suggests that rescue distal thrombectomy could be effective for stroke?

Research has shown that endovascular thrombectomy, a procedure to remove blood clots from arteries, can reduce disability in some stroke patients. Studies have found that this procedure can lead to better recovery, with some patients experiencing significant improvement. For example, one study found that about 39.4% of patients who had clots removed from smaller arteries in the brain showed good recovery. This trial will compare two approaches: participants in one arm will receive conservative management without additional distal intervention, while those in another arm will undergo rescue distal mechanical thrombectomy to remove clots from smaller arteries. This suggests that removing clots from these smaller arteries might improve recovery after a stroke. However, more research is needed to confirm that this method is safe and effective overall.23567

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who have had an acute ischemic stroke caused by a large artery blockage, treated successfully with mechanical clot removal, but still have smaller arteries blocked. Participants must be suitable for either further treatment or observation.

Inclusion Criteria

* Informed consent obtained from the participant or authorized representative, in accordance with the protocol and local regulations
I am 18 years old or older.
I have a recent major stroke with a blocked large brain artery treatable by thrombectomy.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Periprocedural

Treatment

Participants undergo standard proximal mechanical thrombectomy, followed by randomization to either rescue distal mechanical thrombectomy or conservative management during the same endovascular session.

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with imaging and clinical assessments during hospitalization and at 90 days.

90 days
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Rescue Distal Thrombectomy

Trial Overview

The study compares two approaches after initial clot removal in stroke: performing an extra procedure to remove clots from smaller arteries versus no additional intervention. Participants are randomly assigned to one of these groups during their hospital stay.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2. Rescue distal mechanical thrombectomyExperimental Treatment2 Interventions
Group II: Arm 1. Conservative management groupActive Control2 Interventions

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+

Citations

Comparing the Efficacy and Safety of Endovascular Therapy ...

Thirty-seven studies pooling a total of 9,505 patients were included in this meta-analysis. The excellent functional outcome (modified Rankin ...

Rescue Distal Thrombectomy in Treatment for Persistent ...

The goal of this clinical trial is to determine whether rescue distal mechanical thrombectomy can improve outcomes in patients with ...

Trial of Endovascular Thrombectomy for Large Ischemic ...

Endovascular thrombectomy has been shown to be more effective in reducing disability than medical therapy alone in selected patients with ischemic stroke.

Endovascular Treatment in Acute Ischemic Stroke Due to ...

The primary efficacy outcome was 3-month excellent functional outcome (modified Rankin Scale [mRS]-score 0–1), while good functional outcome ( ...

Acute ischaemic stroke interventions: large vessel occlusion ...

Effective recanalisation rates following posterior mechanical thrombectomy using stent retriever were reported in 90% and good functional ...

Rescue therapy after thrombectomy for large vessel occlusion ...

We conclude that glycoprotein IIb/IIIa is a reasonably safe and effective rescue therapy for patients who have had a failed thrombectomy or have residual ...

Mortality Risk in Acute Ischemic Stroke Patients With Large ...

Our meta‐analysis provides evidence that MT reduces by 17% the risk of 3‐month mortality of acute ischemic stroke patients with large vessel occlusion. •. The ...