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Recruiting Not applicable

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

NCT07192029 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-10-12
Last updated
2025-11-17

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Balloon guide catheter combined with conventional thrombectomy treatmentStandard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. age ≥18 years; 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: 1. Pre-stroke mRS score \>2 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.

Primary outcome measure(s)

  • Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion — Perioperative

Trial sites (3)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
Zhangzhou Municipal Hospital Zhangzhou Fujian Recruiting
Xuanwu Hospital, Capital Medical University. Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07192029 on ClinicalTrials.gov ↗ ← All trials in China