An ongoing clinical trial is evaluating the Embolic Protection System for its ability to reduce distal embolism during femoropopliteal debulking procedures, a common concern in treating femoropopliteal disease. Key clinical institutions across China are actively recruiting participants to assess this medical device’s outcomes.
In this article:
- What is the Embolic Protection System?
- What clinical impact does this study hope to achieve?
- Where is the study being conducted?
- FAQ about the study and device
- Key takeaways
- Disclaimer
- Full announcement details
What is the Embolic Protection System?
The Embolic Protection System is a medical device designed to capture and remove embolic debris during vascular interventions. In femoropopliteal procedures, its purpose is to limit distal embolism—a significant complication that can compromise blood flow to the lower limbs. According to the trial’s sponsors, the device represents a proactive measure to safeguard patient outcomes through advanced debris filtering technology.
What clinical impact does this study hope to achieve?
This investigation aims to provide robust evidence supporting the safety and performance of the Embolic Protection System. Success could help refine clinical practices in treating femoropopliteal disease, minimizing embolic complications and enhancing procedural outcomes. Additionally, trial outcomes may influence future regulatory reviews and adoption of embolic protection solutions across more vascular interventions.
Where is the study being conducted?
The trial is sponsored by prominent medical centers, including RenJi Hospital, Xuanwu Hospital in Beijing, and Ruijin Hospital, among others. Recruitment is actively ongoing across multiple leading healthcare institutions throughout China. With its comprehensive multi-center approach, the study aims to ensure diverse patient representation and high-quality data collection rigor for evidence-based conclusions.
FAQ about the study and device
1. Who can participate in the trial?
Participants diagnosed with femoropopliteal disease are eligible, subject to screening criteria established by the recruitment centers.
2. How does the device function?
It uses advanced filter technology to capture embolic debris during debulking procedures, reducing risks associated with distal embolization.
3. Are there safety risks associated with the device?
The study is designed to evaluate both its effectiveness and safety. As a regulated medical device, it adheres to strict protocols to mitigate patient risks.
4. Where can I find more details?
Visit the ClinicalTrials.gov record for comprehensive information about the study.
Key takeaways
This clinical trial represents an important step in advancing vascular intervention technologies. Healthcare professionals, regulatory experts, and device manufacturers should monitor the progress closely for insights that could reshape procedural standards.
Disclaimer
This article serves informational purposes for professionals. It is not a substitute for legal advice or regulatory consultation. Always verify with official trial sources and agencies.
Full announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07282301?term=medical+device