Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07192029

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

Led by Xuanwu Hospital, Beijing · Updated on 2025-11-17

364

Participants Needed

3

Research Sites

63 weeks

Total Duration

On this page

Sponsors

X

Xuanwu Hospital, Beijing

Lead Sponsor

F

Fujian Medical University Union Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of acute ischemic stroke with internal carotid artery occlusion confirmed by imaging (CTA, MRA, or DSA), including I-type, L-type, or T-type occlusions
  • Baseline NIHSS score of 6 or higher, meeting local guidelines for mechanical thrombectomy
  • Time from stroke onset or last known normal to randomization within 24 hours and proceeding to mechanical thrombectomy
  • Signed informed consent by the participant or legal representative
Not Eligible

You will not qualify if you...

  • Pre-stroke modified Rankin Scale (mRS) score greater than 2
  • Intracranial hemorrhage visible on imaging
  • Known or suspected internal carotid artery occlusion caused by dissection or atherosclerosis
  • Vascular tortuosity preventing use of balloon guide catheter
  • Prior stent implantation in the target vessel that would interfere with thrombectomy devices
  • Any condition preventing mechanical thrombectomy
  • Acute occlusion of multiple vascular territories in bilateral anterior circulation or both anterior and posterior circulations
  • Pregnancy
  • Allergy to contrast agents
  • Refusal or inability to cooperate or tolerate interventional procedures
  • Expected life expectancy less than 90 days
  • Midline shift or herniation with ventricular mass effect
  • Unable to participate in follow-up as assessed by investigators
  • Other conditions making balloon guide catheter use unsuitable as determined by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Actively Recruiting

2

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

Actively Recruiting

3

Xuanwu Hospital, Capital Medical University.

Beijing, China, 100053

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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