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Balloon catheter could boost stroke recovery in one go

NCT ID NCT07192029

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 364 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Xuanwu Hospital, Capital Medical University.

    RECRUITING

    Beijing, 100053, China

  • Zhangzhou Municipal Hospital

    RECRUITING

    Zhangzhou, Fujian, China

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