NCT07192029RecruitingNot Applicable
Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial
Xuanwu Hospital, Beijing3 sites in 1 country364 target enrollmentStarted: October 12, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 364
- Locations
- 3
- Primary Endpoint
- Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
The experimental group
Experimental
Intervention: Balloon guide catheter combined with conventional thrombectomy treatment (Procedure)
The control group
Sham Comparator
Intervention: Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment (Procedure)
Outcomes
Primary Outcomes
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion
Time Frame: Perioperative
Secondary Outcomes
- Reperfusion results (eTICI ≥2b, eTICI 3)(Perioperative)
- Proportion of participants with a Barthel Index score of ≥95(90 ± 7 days after surgery)
- 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)
- Number of mechanical thrombectomy attempts(Perioperative)
- Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)(Perioperative)
- Good outcome proportion, defined as mRS score 0-2(90 days (±7 days) post-procedure)
- Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c);(Perioperative)
- EQ-5D-5L score(90 ± 7 days after surgery)
Investigators
Study Sites (3)
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