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?

The goal of this clinical trial is to determine whether rescue distal mechanical thrombectomy can improve outcomes in patients with persistent distal occlusions after successful proximal mechanical thrombectomy for acute ischemic stroke.

Many patients with acute ischemic stroke caused by large vessel occlusion undergo emergency treatment with proximal mechanical thrombectomy, which removes the main clot and restores flow in a large artery. However, in some patients, one or more smaller distal arteries remain occluded after successful proximal recanalization. It is not yet known whether treating these persistent distal occlusions improves angiographic or clinical outcomes.

This study will compare two approaches:

Rescue distal mechanical thrombectomy: an additional distal mechanical thrombectomy procedure is performed during the same endovascular session.

Conservative management: no additional distal endovascular intervention is performed after successful proximal mechanical thrombectomy.

The main questions the study aims to answer are:

* Is rescue distal mechanical thrombectomy feasible in this setting?

* Is it safe?

* Does it improve angiographic and clinical outcomes?

Participants will be randomly assigned during the index endovascular procedure to one of the two study groups and will be followed with imaging and clinical assessments during hospitalization and at 90 days.

Approximately 72 participants will take part in this study at the Centre hospitalier de l'Université de Montréal (CHUM).

Are You a Good Fit for This Trial?

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

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+