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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Zhangzhou Municipal Hospital
  Zhangzhou, Fujian, China Recruiting
• Xuanwu Hospital, Capital Medical University.
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.