Researchers at Beijing Anzhen Hospital have announced a new clinical trial designed to evaluate the combined use of balloon guide catheters and distal filter protection devices for carotid artery stenting procedures. This trial is set to address carotid artery stenosis, a condition that poses significant risks to patients by impeding blood flow to the brain.
Though the trial is not yet recruiting, the medical and regulatory community should take note due to its potential implications for both device performance and patient safety.
In this article
- What changed?
- Who should care?
- Key details of the clinical trial
- FAQ
- Conclusion
- Disclaimer
- Announcement
What changed?
The clinical trial, registered under ClinicalTrials.gov identifier NCT07247864, centers on combining two device technologies: balloon guide catheters and distal filter protection devices. These innovations aim to improve outcomes for patients undergoing carotid artery stenting by minimizing embolic complications during and after the procedure.
The study represents an important milestone as researchers seek evidence-based approaches to enhance current carotid stenting practices.
Who should care?
This development is relevant for clinical teams, regulatory professionals, and medical device manufacturers focusing on vascular interventions and innovations. Understanding the trial’s progress and results may have implications for device development and regulatory approval pathways.
Key details of the clinical trial
Study Overview
Carotid artery stenosis, marked by narrowing or blockage of the carotid arteries, increases stroke risk. Stenting procedures can restore proper blood flow, but embolic events during these interventions remain a major concern.
By combining balloon guide catheters with distal filter protection devices, researchers aim to lower perioperative risks and improve patient safety.
Sponsor and Status
Beijing Anzhen Hospital, noted for its expertise in treating cardiovascular conditions, is the trial’s sponsor. The recruitment phase has not yet started, and additional updates are expected as the preparation progresses.
Innovative Devices
Balloon guide catheters use occlusion methods to prevent debris dislodged during the procedure from traveling upstream. Distal filter protection devices act as a safeguard by capturing embolic particles before they can reach the brain.
This dual approach seeks to address gaps in conventional stenting technologies and raise the bar for both efficacy and patient outcomes.
FAQ
1. What is carotid artery stenosis?
Carotid artery stenosis refers to the narrowing of carotid arteries due to plaque buildup, which restricts blood flow and increases stroke risk.
2. How do balloon guide catheters work?
These catheters temporarily block the artery upstream during interventions to prevent the movement of embolic debris.
3. What is the function of distal filter protection devices?
These devices capture debris downstream, safeguarding against embolic material traveling to the brain.
4. Can I participate in this trial?
Currently, recruitment has not begun, and eligibility criteria will be announced when enrollment opens. Monitor official channels for updates.
Conclusion
This clinical trial highlights the promise of combining advanced device systems to address longstanding challenges in carotid artery stenting. While recruitment has yet to start, medical teams and device manufacturers should watch for results. Insights from this study may inform future regulatory submissions and evidence-based device improvements.
Disclaimer
The information provided is for professionals engaged in regulatory, clinical, or medical device fields. It does not constitute legal advice.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07247864?term=medical+device