RecruitingNot ApplicableNCT06638385

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke

A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke - a Randomized-controlled Multicenter Phase III Trial

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

110 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called DCE + CP and a procedure called DCE + SPACE SHIELD for people with stroke. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREDCE + SPACE SHIELD

Patients receive a DCE with implantation of a space-expanding shield.

PROCEDUREDCE + CP

Patients in the control group receive a DCE similar to the intervention group, but without implantation of a space-expanding shield. Cranioplasty (CP) is performed after \~ 90 days in the customary manner.