Status:
RECRUITING
Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Fujian Medical University Union Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Infa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT07192029
Start Date
October 12 2025
End Date
December 31 2026
Last Update
November 17 2025
Active Locations (3)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
2
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China
3
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053