StrokeNCT07192029
Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery
A study testing Balloon guide catheter combined with conventional thrombectomy treatment and Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment in people with Stroke, run by Xuanwu Hospital, Beijing at 3 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Balloon guide catheter combined with conventional thrombectomy treatment and Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 3 sitesChina
- Study dates
- 12 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
Liqun Jiao, Dr., +86 13911224991, liqunjiao@sina.cn
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Wenhuo Chen, Dr., +8613806906089, 13806906089@126.com
- Recruiting
Zhangzhou Municipal Hospital
Zhangzhou, Fujian
Tingyu Yi, Dr., +86 15859635986, siyuyufen@163.com
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Balloon guide catheter combined with conventional thrombectomy treatment, Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
- Keywords
- Balloon Guide Catheter, Thrombectomy, Internal Carotid Artery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon guide catheter combined with conventional thrombectomy treatmentProcedure or surgery
The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatmentProcedure or surgery
use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Not described Receives: Procedure: Balloon guide catheter combined with conventional thrombectomy treatment |
| The control group | Sham comparator | Not described Receives: Procedure: Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion
Measured: Perioperative
Secondary outcomes (10)
Good outcome proportion, defined as mRS score 0-2
Measured: 90 days (±7 days) post-procedure
Ordinal Distribution of mRS Scores (mRS Shift analysis)
Measured: 90 days (±7 days)
Change in stroke severity (NIHSS score)
Measured: 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
Measured: Perioperative
Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)
Measured: Perioperative
Reperfusion results (eTICI ≥2b, eTICI 3)
Measured: Perioperative
Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c);
Measured: Perioperative
Number of mechanical thrombectomy attempts
Measured: Perioperative
EQ-5D-5L score
Measured: 90 ± 7 days after surgery
Proportion of participants with a Barthel Index score of ≥95
Measured: 90 ± 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start12 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192029
- Sponsor's protocol ID
- IAT-BOOST
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07192029
- Acronym / sponsor ID
- IAT-BOOST
- Conditions
- Stroke
- Keywords
- Balloon Guide Catheter, Thrombectomy, Internal Carotid Artery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon guide catheter combined with conventional thrombectomy treatmentThe experimental group will use balloon guide catheter combined with conventional thrombectomy treatment. | Procedure or surgery | The experimental group |
| Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatmentuse standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment | Procedure or surgery | The control group |
Primary outcome
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion
Time frame: Perioperative
10 secondary outcomes
Good outcome proportion, defined as mRS score 0-2
Time frame: 90 days (±7 days) post-procedure
Ordinal Distribution of mRS Scores (mRS Shift analysis)
Time frame: 90 days (±7 days)
Change in stroke severity (NIHSS score)
Time frame: 7 days or discharge (whichever occurs first);
Technical success rate
Time frame: Perioperative
Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)
Time frame: Perioperative
Reperfusion results (eTICI ≥2b, eTICI 3)
Time frame: Perioperative
Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c);
Time frame: Perioperative
Number of mechanical thrombectomy attempts
Time frame: Perioperative
EQ-5D-5L score
Time frame: 90 ± 7 days after surgery
Proportion of participants with a Barthel Index score of ≥95
Time frame: 90 ± 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon guide catheter combined with conventional thrombectomy treatment and Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment in people with Stroke, run by Xuanwu Hospital, Beijing at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.