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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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

Key facts

Study ID

NCT07192029

Run by

Xuanwu Hospital, Beijing

People needed

364

Starts

2025-10-12

Expected to finish

2026-12-31

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• Zhangzhou Municipal Hospital — Zhangzhou, Fujian, China (enrolling)
• Xuanwu Hospital, Capital Medical University. — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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