A new clinical trial announced on November 18, 2025, aims to evaluate two different thrombectomy techniques for treating patients with acute large vessel occlusion stroke. This study will compare the cyclic Plunger Technique to the Static Manual Aspiration Thrombectomy across safety, efficacy, and performance measures. Sponsored by Vanderbilt University Medical Center and Balt USA, this pivotal research may influence future treatment protocols and device developments in stroke care.
Study Overview
This trial will focus on patients diagnosed with acute ischemic stroke involving large vessel occlusions. These occlusions are a common cause of severe disability and require prompt intervention to restore blood flow to the brain. The study is not yet recruiting but will commence under the oversight of Vanderbilt University Medical Center.
Which Techniques Are Compared?
The two treatment techniques being investigated are the Plunger Technique and the Static Manual Aspiration Thrombectomy:
- Plunger Technique: A cyclic manual aspiration method designed to dislodge and extract clots effectively.
- Static Manual Aspiration Thrombectomy: A simpler approach using consistent manual aspiration forces to remove thrombi.
Both approaches involve direct aspiration, but their differing mechanics and potential outcomes will be evaluated during the trial.
Who Is Eligible?
Patients with acute large vessel occlusion strokes are the primary focus. Specific inclusion and exclusion criteria will determine eligibility to ensure relevant and safe participation. Further details will likely be disclosed upon trial recruitment.
Clinical Significance
The results of this study may provide high-quality evidence on which approach provides better clinical outcomes. The findings could influence device evolution, clinician practices, and regulatory standards in managing ischemic stroke.
Additionally, since strokes are life-threatening conditions requiring immediate care, identifying a superior method could result in improved survival rates and reduced post-stroke disabilities.
FAQ
- What is the purpose of this trial?
The trial aims to compare the safety and effectiveness of two thrombectomy techniques for acute ischemic stroke treatment. - When will the study begin?
The study is currently listed as “Not yet recruiting.” No exact start date has been provided. - Who is conducting the research?
Vanderbilt University Medical Center is leading the trial, with Balt USA as a sponsor. - How might the results impact treatment?
If one technique proves superior, it could guide future clinical practices and refine device designs for better patient outcomes.
Conclusion
The upcoming clinical trial spearheaded by Vanderbilt University Medical Center holds considerable importance for advancing stroke care. By comparing the Plunger Technique to Static Manual Aspiration Thrombectomy, the trial could help define best practices for treating acute ischemic strokes caused by large vessel occlusions. Clinical teams and device manufacturers should monitor the outcomes closely for potential implications in stroke management.
Disclaimer
This content is written for informational purposes only and does not constitute legal or regulatory advice. Always consult with qualified professionals for specific guidance.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07231380?term=medical+device