A new clinical trial is being launched to assess the safety and effectiveness of the AlphaVac Multipurpose Mechanical Aspiration System and the AlphaReturn Blood Management System in treating acute pulmonary embolism. Sponsored by AngioDynamics, Inc., this study represents a critical step toward advancing therapeutic options for this life-threatening condition. As of December 2025, the trial has not yet begun recruiting participants, but professionals in clinical, quality, and regulatory fields should monitor its progress closely.
Trial Details
This upcoming trial will explore how effectively the AlphaVac Multipurpose Mechanical Aspiration System, paired with the AlphaReturn Blood Management System, addresses acute pulmonary embolism—a condition where blood clots obstruct the pulmonary arteries. AngioDynamics, Inc. has designed these devices to manage clot removal while maintaining hemodynamic stability.
At present, the trial detailed on ClinicalTrials.gov has not started participant recruitment. Professionals in clinical research and regulatory fields should remain informed as updates emerge. Successful outcomes may influence treatment protocols and device clearance processes.
How Do the Systems Work?
The AlphaVac Multipurpose Mechanical Aspiration System utilizes mechanical suction to extract blood clots from the pulmonary vasculature. The AlphaReturn Blood Management System complements this functionality by facilitating efficient circulation and minimizing blood loss during the procedure. Together, these devices aim to provide targeted clot removal while protecting patients from the risks of hemodynamic instability during treatment.
These systems represent a novel approach to addressing acute pulmonary embolism, focusing on improving procedural safety and efficacy.
What Are the Research Goals?
The trial has been structured to evaluate three fundamental aspects:
- Safety: Ensuring that both devices perform without causing undue harm or adverse events.
- Effectiveness: Measuring the degree of clot resolution and other clinical improvements.
- Performance: Confirming that both systems operate as intended under real-world conditions.
This research aligns with the medical device regulatory obligations to validate safety, performance, and intended use before broader adoption. Data from this study may contribute to regulatory decisions and future device iterations.
Frequently Asked Questions
- When will recruitment begin?
The trial is listed as “not yet recruiting” as of December 13, 2025. Updates are anticipated in the coming months. - Who can participate?
General inclusion and exclusion criteria were not detailed in the provided information. Specific eligibility will likely be outlined upon recruitment initiation. - Where can I find more details?
Visit the ClinicalTrials.gov page for additional updates: NCT07280247.
Conclusion
The upcoming trial examining the AlphaVac and AlphaReturn devices could lead to important advancements in acute pulmonary embolism treatment. Clinical, quality, and regulatory professionals should follow this study closely to track its impact on therapeutic practices and device evaluations.
Disclaimer
This article is for informational purposes only and should not be considered legal or regulatory advice. Professionals must consult official sources and guidance documents for compliance determinations.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07280247?term=medical+device