Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT07192029
• Lead Sponsor: Xuanwu Hospital, Beijing

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Study Start: 2025-10-15
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 364

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 of 0-2
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion	Perioperative

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, China