Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery
NCT ID: NCT07192029
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
364 participants
INTERVENTIONAL
2025-10-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The experimental group
Balloon guide catheter combined with conventional thrombectomy treatment
The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
The control group
Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
Interventions
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Balloon guide catheter combined with conventional thrombectomy treatment
The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
Eligibility Criteria
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Inclusion Criteria
2. 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);
3. Baseline NIHSS≥6, and meeting local guidelines for mechanical thrombectomy;
4. Time from onset or last known normal to randomization within 24 hours and proceeding to mechanical thrombectomy;
5. Signed informed consent (or by legal representative).
Exclusion Criteria
2. Intracranial hemorrhage shown on imaging;
3. Known or suspected internal carotid artery occlusion caused by dissection or atherosclerosis;
4. Vascular tortuosity preventing the use of balloon guide catheter;
5. Prior stent implantation in the target vessel that would impede the use or removal of mechanical thrombectomy devices;
6. Any other circumstances impeding mechanical thrombectomy implementation;
7. Acute occlusion of multiple vascular territories in bilateral anterior circulation or in both the anterior and posterior circulations confirmed by CTA/MRA;
8. Pregnant subjects;
9. Subjects allergic to contrast agents;
10. Subjects refusing to cooperate or unable to tolerate interventional procedures;
11. Subjects whose expected lifetime are less than 90 days;
12. Midline shift or herniation with ventricular mass effect;
13. Subjects deemed unable to participate in follow-up by investigators;
14. Other situations deemed unsuitable for balloon guide catheter use by investigators.
18 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Zhangzhou Affiliated Hospital of Fujian Medical University
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China
Xuanwu Hospital, Capital Medical University.
Beijing, , China
Countries
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Facility Contacts
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Other Identifiers
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IAT-BOOST
Identifier Type: -
Identifier Source: org_study_id
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