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

NCT ID: NCT07192029

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-12

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The experimental group

Group Type EXPERIMENTAL

Balloon guide catheter combined with conventional thrombectomy treatment

Intervention Type PROCEDURE

The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.

The control group

Group Type SHAM_COMPARATOR

Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Intervention Type PROCEDURE

use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Interventions

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Balloon guide catheter combined with conventional thrombectomy treatment

The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.

Intervention Type PROCEDURE

Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

Site Status RECRUITING

Xuanwu Hospital, Capital Medical University.

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Wenhuo Chen, Dr.

Role: primary

+8613806906089

Tingyu Yi, Dr.

Role: primary

+86 15859635986

Liqun Jiao, Dr.

Role: primary

+86 13911224991

Other Identifiers

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IAT-BOOST

Identifier Type: -

Identifier Source: org_study_id

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