Recruiting
Not applicable
Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery
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
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)
| Facility | City | Region | Status |
| Fujian Medical University Union Hospital |
Fuzhou |
Fujian |
Recruiting |
| Zhangzhou Municipal Hospital |
Zhangzhou |
Fujian |
Recruiting |
| Xuanwu Hospital, Capital Medical University. |
Beijing |
China |
Recruiting |
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