Using a balloon guide catheter to improve clot removal for internal carotid artery stroke

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial

This will test whether using a balloon guide catheter during mechanical thrombectomy helps people with acute ischemic stroke from an internal carotid artery blockage achieve better blood flow on the first pass.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 364 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 3 sites (Fuzhou, Fujian and 2 other locations)
• Trial ID: NCT07192029 on ClinicalTrials.gov

What this trial studies

Adults with acute ischemic stroke caused by internal carotid artery occlusion and baseline NIHSS ≥6 who present within 24 hours are enrolled at multiple hospitals in Beijing and Fujian. Participants are assigned to receive either a balloon guide catheter with flow arrest or a standard guide catheter/neurovascular sheath as part of their mechanical thrombectomy procedure. The main outcome is the rate of first-pass expanded Thrombolysis in Cerebral Infarction (eTICI 2c-3) reperfusion. The trial compares reperfusion success between the two approaches to see if flow arrest with a balloon guide catheter improves immediate recanalization.

Who should consider this trial

Good fit: Adults (≥18 years) with imaging-confirmed internal carotid artery occlusion causing acute ischemic stroke, NIHSS ≥6, within 24 hours of symptom onset and eligible for mechanical thrombectomy who can provide consent are ideal candidates.

Not a fit: Patients with pre-stroke disability (mRS >2), intracranial hemorrhage on imaging, occlusion due to dissection or atherosclerosis, or vascular anatomy that prevents device delivery are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, using a balloon guide catheter could increase first-pass complete reperfusion rates, which may lead to faster recanalization and better recovery for patients.

How similar studies have performed: Observational and device-focused reports have suggested balloon guide catheters can improve reperfusion and reduce distal emboli, but randomized data specifically for internal carotid artery occlusions remain limited.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian and 2 other locations

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

Conditions: Stroke, Balloon Guide Catheter, Thrombectomy, Internal Carotid Artery