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

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: Balloon guide catheter combined with conventional thrombectomy treatment; Procedure: Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

• Study Type: Interventional
• Enrollment (Estimated): 364
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University.
    • Contact: Liqun Jiao, Dr.; Phone Number: +86 13911224991; Email: liqunjiao@sina.cn
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Wenhuo Chen, Dr.; Phone Number: +8613806906089; Email: 13806906089@126.com
    • Zhangzhou, Fujian, China
      • Recruiting
      • Zhangzhou Municipal Hospital
      • Contact: Tingyu Yi, Dr.; Phone Number: +86 15859635986; Email: siyuyufen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group	Procedure: Balloon guide catheter combined with conventional thrombectomy treatment; The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
Sham Comparator: The control group	Procedure: Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment; use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Defined as the successful delivery of the guiding catheter to the target vessel and completion of the thrombectomy process without replacing the guiding catheter	Perioperative
Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)		Perioperative
Reperfusion results (eTICI ≥2b, eTICI 3)		Perioperative
Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c);		Perioperative
Number of mechanical thrombectomy attempts		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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Fujian Medical University Union Hospital; Zhangzhou Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Estimated): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Thrombectomy; Balloon Guide Catheter; Internal Carotid Artery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: IAT-BOOST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No