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

NCT07192029 | Recruiting DMC

• 1 other identifier: IAT-BOOST
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 3

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

Conditions

Stroke

Keywords

Balloon Guide Catheter; Thrombectomy; Internal Carotid Artery

Outcome Measures

Primary Outcomes (1)

• Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion

  Perioperative

Secondary Outcomes (10)

• 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

• Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)

  Perioperative

Study Arms (2)

The experimental group

EXPERIMENTAL

Procedure: Balloon guide catheter combined with conventional thrombectomy treatment

The control group

SHAM COMPARATOR

Procedure: Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Interventions

Balloon guide catheter combined with conventional thrombectomy treatment PROCEDURE

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

The experimental group

Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment PROCEDURE

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

The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Fujian Medical University Union Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (3)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

RECRUITING

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 25, 2025
• Study Start: October 12, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)