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Balloon catheters may improve stroke clot removal

NCT ID NCT07478042

Disease control Sponsor: University Hospital Heidelberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a balloon-guided catheter helps doctors remove blood clots more effectively in people having a stroke. 110 adults with acute ischemic stroke were randomly assigned to receive clot removal with either a balloon-guided or standard catheter. The main goal was to see how well blood flow was restored after the procedure.

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 balloon-guided catheters prove better, this could lead to more effective and safer clot removal for stroke patients, potentially improving recovery.
What could go wrong
This is a small, single-center study (110 patients), so results may not apply broadly. The devices are already approved, so the benefit over standard catheters may be small or absent.

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

110 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

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: * Patients with an acute ischemic stroke * Location of the primary occlusion in the anterior cerebral circulation * Pre-therapeutic modified Rankin Scale (mRS) score of ≤ 3. * Written informed consent from 1. the patient or 2. their legal representative/guardian or 3. patient enrollment by an independent physician and the principal investigator Exclusion Criteria: * Patients with contraindications to interventional therapy * Patients with acute intracranial hemorrhage * Pregnancy/Breastfeeding * Pre-therapeutic mRS \> 3 * National Institute of Health Stroke Scale (NIHSS) ≤ 4 * Patients detained in an institution by court or government order * Patients who require intubation for treatment

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Acute ischemic stroke (AIS) Acute ischemic stroke patients

Contacts and locations

Locations

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

More trials for these conditions

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