Balloon catheter could boost stroke recovery in one go
NCT ID NCT07192029
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a balloon guide catheter during mechanical thrombectomy (a procedure to remove blood clots) can improve blood flow restoration in a single attempt for people with acute ischemic stroke caused by internal carotid artery blockage. About 364 participants will be randomly assigned to receive either the balloon catheter or a standard catheter. The main goal is to see if the balloon catheter leads to better first-pass reperfusion, which could mean fewer complications and better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- balloon guide catheter
- What this could lead to
- If it works, this could improve the chances of restoring blood flow in a single attempt during stroke treatment, potentially leading to better recovery.
- What could go wrong
- This is a mid-stage trial with 364 participants, so results may not apply to all stroke patients. The procedure carries standard risks of catheter use, such as vessel damage or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 364 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Medical University Union Hospital
RECRUITINGFuzhou, Fujian, China
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Xuanwu Hospital, Capital Medical University.
RECRUITINGBeijing, 100053, China
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Zhangzhou Municipal Hospital
RECRUITINGZhangzhou, Fujian, China
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Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next