Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy - A PHASE II Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of participants successfully randomized among screen-eligible participants
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Poor expected 3-month prognosis due to comorbid conditions
- •Opposition by the participant or, in emergency inclusion circumstances, by an authorized representative
研究组 & 干预措施
Arm 1. Conservative management group
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.
干预措施: Proximal mechanical thrombectomy (Procedure)
Arm 1. Conservative management group
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.
干预措施: Conservative management (Other)
Arm 2. Rescue distal mechanical thrombectomy
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.
干预措施: Proximal mechanical thrombectomy (Procedure)
Arm 2. Rescue distal mechanical thrombectomy
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.
干预措施: Rescue distal mechanical thrombectomy (Procedure)
结局指标
主要结局
Number of participants successfully randomized among screen-eligible participants
时间窗: Periprocedural
Number of screen-eligible participants who are successfully randomized during the index endovascular procedure.
次要结局
- 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.)
- Rate of complete reperfusion (mTICI 3)(Immediate post procedure)
- Procedure time(During the endovascular procedure)
- Number of intracranial thrombectomy passes(During the endovascular procedure)
- Disposition(At 90 days)
- Rate of mortality(At 24 hours and 90 days)
- Rate of procedural complications(During the endovascular procedure)
- Median score of reperfusion (AOL)(immediate post-procedure)