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).
Age ≥ 18 years
Acute ischemic stroke with proximal large vessel occlusion (M1, M2, ICA, or basilar artery) treatable with mechanical thrombectomy
Presence of one or more persistent distal occlusions (M2-M4, A1-A5, or P1-P5) after successful proximal mechanical thrombectomy
The participant is considered suitable for either rescue distal mechanical thrombectomy or conservative management in the event of persistent distal occlusion
Poor expected 3-month prognosis due to comorbid conditions
Opposition by the participant or, in emergency inclusion circumstances, by an authorized representative
Parallel
Proximal mechanical thrombectomy
Procedure/SurgeryMechanical thrombectomy performed for the qualifying proximal large vessel occlusion before assessment of eligibility for randomization.
Rescue distal mechanical thrombectomy
Procedure/SurgeryRescue distal mechanical thrombectomy performed during the same endovascular session after successful proximal recanalization to treat persistent distal medium-vessel occlusion identified on angiography.
Conservative management
Other interventionNo additional distal endovascular intervention after successful proximal mechanical thrombectomy. Participants continue with standard medical and post-procedural care.
Number of participants successfully randomized among screen-eligible participants
Number of screen-eligible participants who are successfully randomized during the index endovascular procedure.
Median modified Rankin Scale (mRS) score at 90 days
Median score on the modified Rankin Scale (0 to 6), where lower scores indicate less disability.
Proportion of functional independence as measured by the modified Rankin scale (0-2)
The modified Rankin Scale (mRS) is a 7-point ordinal scale (0-6) used to assess global disability and functional outcome, particularly after stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability
Median change in NIHSS score (Delta NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurological examination used to quantify stroke severity. Scores range from 0 to 42, with higher scores indicating more severe neurological deficits. It is widely used in clinical trials to assess baseline severity and early neurological outcomes.
Proportion of NIHSS improvement ≥ 4 points
The National Institutes of Health Stroke Scale (NIHSS) is a standardized 15-item neurological examination used to quantify stroke severity. Scores range from 0 to 42, with higher scores indicating more severe neurological deficits. It is widely used in clinical trials to assess baseline severity and early neurological outcomes.
Number of participants with symptomatic intracerebral hemorrhage
Number of enrolled participants with symptomatic intracerebral hemorrhage.
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