Rescue Distal Thrombectomy in Treatment for Persistent Distal Occlusions

NCT07533253 | Not Yet Recruiting

• 1 other identifier: 2026-12956
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Ischemic Stroke

Keywords

thrombectomy; endovascular treatment; distal occlusion

Outcome Measures

Primary Outcomes (1)

• Number of participants successfully randomized among screen-eligible participants

  Number of screen-eligible participants who are successfully randomized during the index endovascular procedure.

  Periprocedural

Secondary Outcomes (12)

• Median modified Rankin Scale (mRS) score at 90 days

  90 days

• Proportion of functional independence as measured by the modified Rankin scale (0-2)

  At 90 days

• Median change in NIHSS score (Delta NIHSS)

  At 24 hours

• Proportion of NIHSS improvement ≥ 4 points

  At 24 hours

• Median score of reperfusion (mTICI)

  Immediate post-procedure.

Other Outcomes (1)

• Number of participants with symptomatic intracerebral hemorrhage

  24 hours

Study Arms (2)

Arm 1. Conservative management group

ACTIVE COMPARATOR

Participants first undergo standard proximal mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion. If a persistent distal medium-vessel occlusion remains after successful proximal recanalization, they are randomized to no additional distal endovascular intervention and continue with standard medical and post-procedural care.

Procedure: Proximal mechanical thrombectomy; Other: Conservative management

Arm 2. Rescue distal mechanical thrombectomy

EXPERIMENTAL

Participants first undergo standard proximal mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion. If a persistent distal medium-vessel occlusion remains after successful proximal recanalization, they are randomized to rescue distal mechanical thrombectomy during the same endovascular session.

Procedure: Proximal mechanical thrombectomy; Procedure: Rescue distal mechanical thrombectomy

Interventions

Proximal mechanical thrombectomy PROCEDURE

Mechanical thrombectomy performed for the qualifying proximal large vessel occlusion before assessment of eligibility for randomization.

Arm 1. Conservative management group; Arm 2. Rescue distal mechanical thrombectomy

Rescue distal mechanical thrombectomy PROCEDURE

Rescue distal mechanical thrombectomy performed during the same endovascular session after successful proximal recanalization to treat persistent distal medium-vessel occlusion identified on angiography.

Arm 2. Rescue distal mechanical thrombectomy

Conservative management OTHER

No additional distal endovascular intervention after successful proximal mechanical thrombectomy. Participants continue with standard medical and post-procedural care.

Arm 1. Conservative management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed consent obtained from the participant or authorized representative, in accordance with the protocol and local regulations

You may not qualify if:

• Poor expected 3-month prognosis due to comorbid conditions

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W 0C1, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Guylaine Gevry, BSc. Project manager

CONTACT

+1 514 890-8000; neuroradiologie.recherche.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase II, single-center, randomized, controlled, open-label trial with blinded outcome assessment (PROBE design). Participants with acute ischemic stroke and persistent distal occlusions after successful proximal mechanical thrombectomy are randomly assigned (1:1) during the index endovascular procedure to either rescue distal mechanical thrombectomy or conservative management. Randomization is stratified by age, thrombolysis use, and occlusion location. Although the treatment team is aware of treatment allocation, key angiographic and clinical outcomes are assessed by independent blinded evaluators. The study follows a pragmatic design with broad inclusion criteria and minimal protocol-imposed procedures beyond standard care.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)