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New stroke surgery could spare patients a second operation

NCT ID NCT07195786

Disease control Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new surgical technique called Expansion-floating Craniotomy (EC) for people with life-threatening brain swelling after a massive stroke. The standard surgery removes a piece of skull to relieve pressure, but requires a second surgery months later to replace the bone. EC aims to keep the bone attached using temporary metal plates, potentially avoiding the second surgery. The study will compare outcomes in 356 adults to see if EC is as safe and effective as the standard approach.

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.

Participants

About 356 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

May 2027

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.

Who is studied

Subjects developing malignant cerebral edema after acute cerebral infarction

Ages

18 to 80 years

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: * Age requirement: Adults aged \>18 but \<80 years * Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria: NIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating \>50% MCA territory infarction or hypoperfused area \>2/3, OR DWI hyperintensity volume \>82 ml within 6 hours of onset, OR DWI infarct volume \>145 ml within 14 hours * Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci/cisterns. Exclusion Criteria: * Pre-stroke mRS score ≥1 * Significant contralateral cerebral infarction * Symptomatic intracranial hemorrhage * Any known coagulopathy * Life expectancy \<3 years * Any severe comorbidities potentially interfering with treatment evaluation

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Conditions

The condition(s) this trial relates to.

brain edema ischemic stroke

As listed by the trial registrant

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

Ischemic stroke, acute Malignant cerebral edema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.