RecruitingNot ApplicableNCT07192029

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial


Sponsor

Xuanwu Hospital, Beijing

Enrollment

364 participants

Start Date

Oct 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate whether using balloon guide catheter with flow arrest during mechanical thrombectomy, compared to non-flow arrest, improves the rate of first pass expanded Thrombolysis in Cerebral Infarction score (eTICI 2c-3) reperfusion for acute ischemic stroke due to internal carotid artery occlusion


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • age ≥18 years;
  • Clinical diagnosis of acute ischemic stroke with internal carotid artery occlusion confirmed by imaging (CTA/MRA/DSA), including isolated intracranial internal carotid artery (I-type), internal carotid artery intracranial segment involving middle cerebral artery (L-type), or internal carotid artery intracranial segment involving middle and anterior cerebral arteries (T-type) (including tandem embolic occlusions of the internal carotid artery C1 or common carotid artery);
  • Baseline NIHSS≥6, and meeting local guidelines for mechanical thrombectomy;
  • Time from onset or last known normal to randomization within 24 hours and proceeding to mechanical thrombectomy;
  • Signed informed consent (or by legal representative).

Exclusion Criteria14

  • Pre-stroke mRS score >2
  • Intracranial hemorrhage shown on imaging;
  • Known or suspected internal carotid artery occlusion caused by dissection or atherosclerosis;
  • Vascular tortuosity preventing the use of balloon guide catheter;
  • Prior stent implantation in the target vessel that would impede the use or removal of mechanical thrombectomy devices;
  • Any other circumstances impeding mechanical thrombectomy implementation;
  • Acute occlusion of multiple vascular territories in bilateral anterior circulation or in both the anterior and posterior circulations confirmed by CTA/MRA;
  • Pregnant subjects;
  • Subjects allergic to contrast agents;
  • Subjects refusing to cooperate or unable to tolerate interventional procedures;
  • Subjects whose expected lifetime are less than 90 days;
  • Midline shift or herniation with ventricular mass effect;
  • Subjects deemed unable to participate in follow-up by investigators;
  • Other situations deemed unsuitable for balloon guide catheter use by investigators.

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Interventions

PROCEDUREBalloon guide catheter combined with conventional thrombectomy treatment

The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.

PROCEDUREStandard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment


Locations(3)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

Xuanwu Hospital, Capital Medical University.

Beijing, China

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NCT07192029


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