Proximal TEmporary oCclusion Using Balloon Guide Catheter for Mechanical Thrombectomy (PROTECT-MT)

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

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.

defined as successfully navigating the guide catheter into target vessel, and finishing the MT procedure without changing another guide catheter

Intracranial hemorrhage, symptomatic intracranial hemorrhage or asymptomatic intracranial hemorrhage at 7 days post treatment or discharge (whichever occurs first)

Any Procedural complications, including vessel dissection, arterial perforation, and femoral access complications, etc.

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

Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.

The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.