Surgical removal of necrotic tissue in stroke patients
Strokectomy in Malignant Cerebral Media Infarction: A Pilot Study
This study is testing a new surgery to remove dead tissue in stroke patients to see if it works better and has fewer problems than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rostock Academic / other |
| Locations | 1 site (Rostock, Mecklenburg-Vorpommern) |
| Trial ID | NCT06489470 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of strokectomy, a surgical procedure that involves the resection of necrotic tissue in patients suffering from malignant middle cerebral artery (MCA) infarction. The aim is to evaluate this alternative to the standard decompressive hemicraniectomy (DC), which is currently the recommended treatment for this condition. By including patients with acute unilateral MCA infarction, the study seeks to determine if this approach can improve outcomes and reduce complications associated with traditional surgical methods. The study will assess the safety and effectiveness of this intervention in a pilot setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with acute ischemic MCA infarction affecting at least two-thirds of the MCA territory.
Not a fit: Patients with significant preexisting disability, severe neurological impairment, or contraindications for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and better functional outcomes for patients with malignant MCA infarction.
How similar studies have performed: While decompressive hemicraniectomy has been well-studied and shown to be effective, the specific approach of strokectomy is novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Ischemic middle cerebral artery (MCA) infarction at least two thirds of the MCA territory * Clinical symptoms of acute unilateral MCA infarction less than 48 hours prior to the initiation of treatment Exclusion Criteria: * Preexisting modified Rankin Scale \>2 * Absence of pupillary reflexes or GCS \<6 * Intracerebral hemorrhage or other associated brain lesions * Contraindications for surgery * Estimated life expectancy of less than 3 years
Where this trial is running
Rostock, Mecklenburg-Vorpommern
- University Medical Center Rostock — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
Study contacts
- Principal investigator: Sae-Yeon Won, MD — Neurosurgery, University Medical Center Rostock
- Study coordinator: Melanie Sparre
- Email: melanie.sparre@med.uni-rostock.de
- Phone: 0381 494 6419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.