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Acute Ischemic Stroke2BE3-PhaseIINCT07533253

Rescue Distal Thrombectomy in Treatment for Persistent Distal Occlusions

A study testing Proximal mechanical thrombectomy, Rescue distal mechanical thrombectomy and Conservative management in people with Acute Ischemic Stroke, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Proximal mechanical thrombectomy, Rescue distal mechanical thrombectomy and Conservative management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteCanada
Study dates
1 Sep 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Poor expected 3-month prognosis due to comorbid conditions
  • Opposition by the participant or, in emergency inclusion circumstances, by an authorized representative

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2W 0C1

    Daniela E. Iancu Associate professor of Radiology, Neuroradiologist, MD

Other trials in Canada

About this study

Official title: Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy - A PHASE II 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.

Read more

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).

Read the detailed description

The 2BE3 - Phase II study is a clinical trial designed to evaluate the feasibility and safety of rescue distal mechanical thrombectomy in patients with persistent distal occlusions following successful proximal recanalization.

Endovascular thrombectomy has become the standard of care for acute ischemic stroke caused by large vessel occlusion (LVO), with substantial improvement in clinical outcomes demonstrated in multiple randomized trials. However, despite successful recanalization of the primary occlusion, a proportion of patients continue to have persistent distal occlusions or incomplete reperfusion, which may limit neurological recovery. Residual distal occlusions, particularly in medium- and distal-vessel territories, remain an important and insufficiently studied contributor to suboptimal outcomes after thrombectomy.

The optimal management of persistent distal occlusions after successful proximal thrombectomy remains uncertain. In current practice, some operators perform rescue distal mechanical thrombectomy, whereas others do not perform additional distal endovascular intervention because of concerns related to vessel injury, hemorrhagic complications, or prolonged procedure time. As a result, management remains variable and is not currently guided by high-level evidence.

This is a randomized, controlled, open-label trial with blinded outcome assessment (PROBE design). Approximately 72 adult patients with acute ischemic stroke who undergo successful proximal mechanical thrombectomy but have one or more persistent distal occlusions will be enrolled. During the index endovascular procedure, eligible participants will be randomly assigned to one of two study groups:

Rescue distal mechanical thrombectomy group: participants undergo rescue distal mechanical thrombectomy during the same endovascular session.

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

The primary objective of the study is to evaluate the feasibility and safety of rescue distal mechanical thrombectomy in this clinical setting. Secondary objectives include evaluating angiographic reperfusion, functional outcome at 90 days, early neurological improvement, and procedure-related safety outcomes.

Because this study is conducted in an emergency stroke setting, the consent process is adapted to the participant's clinical condition. Whenever possible, informed consent is obtained directly from the participant before inclusion. If the participant lacks decision-making capacity, consent is obtained from an authorized representative, in accordance with applicable local regulations and ethics requirements. If decision-making capacity is regained, the participant is informed about the study and continued participation is confirmed according to the protocol.

The trial is conducted at the Centre hospitalier de l'Université de Montréal (CHUM). All procedures included in the study are already used in routine clinical stroke care. Data are collected securely using the REDCap system, and imaging and clinical outcomes are assessed by independent evaluators blinded to treatment allocation.

This phase II trial is intended to generate feasibility, safety, and preliminary outcome data to inform the design of a future larger study. The results may help guide treatment decisions for patients with persistent distal occlusions after proximal thrombectomy.

Being tested
Proximal mechanical thrombectomy, Rescue distal mechanical thrombectomy, Conservative management
Keywords
thrombectomy, endovascular treatment, distal occlusion
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proximal mechanical thrombectomyProcedure or surgery

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

  • Rescue distal mechanical thrombectomyProcedure or surgery

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

  • Conservative managementOther

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

Study groups in NCT07533253
Study groupRoleWhat they receive
Arm 1. Conservative management groupActive comparatorParticipants 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.
Receives: Procedure: Proximal mechanical thrombectomy; Other: Conservative management
Arm 2. Rescue distal mechanical thrombectomyExperimentalParticipants 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.
Receives: Procedure: Proximal mechanical thrombectomy; Procedure: Rescue distal mechanical thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants successfully randomized among screen-eligible participants

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

    Measured: Periprocedural

Secondary outcomes (12)
  1. 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.

    Measured: 90 days

  2. 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

    Measured: At 90 days

  3. 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.

    Measured: At 24 hours

  4. 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.

    Measured: At 24 hours

  5. Median score of reperfusion (mTICI)

    Reperfusion will be assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) scale (0-3) Higher grades indicate better reperfusion. Final angiographic outcomes will be adjudicated by a blinded core laboratory.

    Measured: Immediate post-procedure.

  6. Rate of complete reperfusion (mTICI 3)

    Complete reperfusion is defined as mTICI grade 3 on final angiography, indicating full restoration of antegrade flow in the affected vascular territory. Assessment will be performed by a blinded core laboratory.

    Measured: Immediate post procedure

  7. Procedure time

    Procedure time is defined as the interval between arterial puncture and acquisition of the final angiographic run. It reflects procedural efficiency.

    Measured: During the endovascular procedure

  8. Number of intracranial thrombectomy passes

    The number of device passes required to achieve final reperfusion during the endovascular procedure. Fewer passes may reflect higher procedural efficiency and effectiveness.

    Measured: During the endovascular procedure

  9. Disposition

    Patient disposition at 90 days will be categorized as home, rehabilitation center, hospital, or death, reflecting post-stroke functional status and care needs

    Measured: At 90 days

  10. Rate of mortality

    All-cause mortality will be assessed to capture early and late death following the index event and intervention

    Measured: At 24 hours and 90 days

  11. Rate of procedural complications

    Procedural complications include vascular perforation, arterial dissection, and embolization to new vascular territories occurring during the endovascular procedure.

    Measured: During the endovascular procedure

  12. Median score of reperfusion (AOL)

    Reperfusion will be assessed using the modified Thrombolysis in Cerebral Infarction (AOL) scale (0-III) Higher grades indicate better reperfusion. Final angiographic outcomes will be adjudicated by a blinded core laboratory.

    Measured: immediate post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533253
Sponsor's protocol ID
2026-12956
Acronym
2BE3-PhaseII
Status last verified
Apr 2026
First submitted
3 Feb 2026
Last updated
16 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We may consider sharing de-identified individual participant data (IPD) upon reasonable request, after study completion and publication of primary results. Any data sharing will be subject to applicable ethical approvals, data use agreements, and privacy regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Proximal mechanical thrombectomy, Rescue distal mechanical thrombectomy and Conservative management in people with Acute Ischemic Stroke, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guylaine Gevry, BSc. Project manager (+1 514 890-8000 ext. 27235, neuroradiologie.recherche.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants successfully randomized among screen-eligible participants (time frame: Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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