Stroke
Conditions
Keywords
Balloon Guide Catheter, Thrombectomy, Internal Carotid Artery
Brief 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
Interventions
PROCEDUREBalloon guide catheter combined with conventional thrombectomy treatment
The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
PROCEDUREStandard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
Sponsors
Fujian Medical University Union Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion | Perioperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Good outcome proportion, defined as mRS score 0-2 | 90 days (±7 days) post-procedure | — |
| Ordinal Distribution of mRS Scores (mRS Shift analysis) | 90 days (±7 days) | — |
| Change in stroke severity (NIHSS score) | 7 days or discharge (whichever occurs first); | — |
| Technical success rate | Perioperative | Defined as the successful delivery of the guiding catheter to the target vessel and completion of the thrombectomy process without replacing the guiding catheter |
| Number of mechanical thrombectomy attempts | Perioperative | — |
| Reperfusion results (eTICI ≥2b, eTICI 3) | Perioperative | — |
| Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c); | Perioperative | — |
| EQ-5D-5L score | 90 ± 7 days after surgery | — |
| Proportion of participants with a Barthel Index score of ≥95 | 90 ± 7 days after surgery | — |
| Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3) | Perioperative | — |
Countries
China
Outcome results
None listed