Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy

Study Overview
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Brief Summary
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A multi-center, prospective, randomized, open-label, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS.

Detailed Description
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The PROTECT-MT study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation (PROBE) trial, and aims to determine the effectiveness of balloon guide catheter(BGC) as compared to standard guide catheter on functional outcome (modified Rankin Scale [mRS] score at Day 90 of 0-2) in patients with acute ischemic stroke due to anterior circulation large vessel occlusion. Primary Endpoints Functional outcome, defined as modified Rankin Scale (mRS) score of 0-2, at 90 days (±14 days) . Secondary Endpoints Dichotomized mRS at 90 days after the operation (0-1 versus 2-6, 0-3 versus 4-6, 0-4 versus 5-6, 0-5 versus 6). Change in stroke severity (NIHSS score) at 24 hours post treatment. Change in stroke severity (NIHSS score) at 7 days post treatment or discharge (whichever occurs first). Final infarct volume at 5-7 days Technical success rate (defined as successfully navigating the guide catheter into the target vessel, and finishing the mechanical thrombectomy procedure without changing to another guide catheter). Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) in final angiogram. Reperfusion outcome (eTICI 2b or greater, eTICI 2c or greater, eTICI 3) after the first pass. Time from groin puncture to successful reperfusion (eTICI 2b or greater, eTICI 2c or greater). Percentage of subjects with acceptable revascularization quality (eTICI 2b or greater, eTICI 2c or greater) within 45 min of access. Number of thrombectomy attempts (final). Occurrence of emboli to a new territory. Safety Endpoints: Deaths at 90 days (±14 days) post treatment. Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first). Other serious adverse events (SAEs) adjudicated by the Clinical Events Committee. Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.

Official Title
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PROximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy(PROTECT-MT)

Conditions
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Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Thrombosis

Intervention / Treatment
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* Procedure: Balloon guide catheters (BGCs)
* Procedure: Standard guide catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Acute ischemic stroke, caused by a large vessel occlusion of the anterior circulation cerebral artery confirmed on brain imaging (intracranial carotid artery or middle M1/proximal M2) Femoral artery puncture can be finished within 24 hours of symptom onset based on local practice Pre-event modified Rankin Scale score 0-1 Written informed consent obtained (by patient or appropriate proxy, according to local requirements) Exclusion Criteria: Intracranial hemorrhage on imaging Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory Excessive vascular access tortuosity that navigating BGCs would be impossible Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neuro-thrombectomy device Any other condition precludes performing MT procedure Occlusions in multiple vascular territories confirmed on CTA/MRA Pregnancy Allergy to contrast agents Patients refuse to cooperate or unable to tolerate interventional operation Expected lifetime<90 days Unlikely to participate in follow-up assessments Any other condition that, in the opinion of the investigator, not suitable for BGCs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Balloon guide catheters (BGCs) | Procedure: Balloon guide catheters (BGCs)<br>* MT procedure with Balloon guide catheters (BGCs)<br>|
| Active Comparator: Control group<br>Standard guide catheter | Procedure: Standard guide catheter<br>* MT procedure with standard guide catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | defined as modified Rankin Scale (mRS) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomized mRS | Dichotomized mRS (0-1 versus 2-6,0-2 versus 3-6,0-3 versus 4-6,0-4 versus 5-6,0-5 versus 6) | 90 days | 
| Change in stroke severity | NIHSS | 24 hours post treatment | 
| Change in stroke severity | NIHSS | 7 days post treatment or discharge (whichever occurs first). | 
| Technical success rate | defined as successfully navigating the guide catheter into target vessel, and finishing the MT procedure without changing another guide catheter | 24 hours after MT | 
| Reperfusion outcome | (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3)in Final angiogram. | 24 hours after MT | 
| Reperfusion result | (eTICI 2b or greater ,eTICI 2c or greater, eTICI 3) after First pass | 24 hours after MT | 
| Time from groin puncture to successful reperfusion | ( eTICI 2c or greater） | 24 hours after MT | 
| Revascularization quality | (eTICI 2c or greater) within 45 min of access | 24 hours after MT | 
| Thrombectomy attempt (final) | Number of MT (final) | 24 hours after MT | 
| Occurrence of emboli to a new territory | Occurrence of emboli to a new territory | 90 days | 
| Final infarct volume | Final infarct volume at 5-7 days | 5-7 days after MT |