A new clinical trial announced on October 5, 2025, aims to assess the performance and safety of a drug-coated peripheral balloon dilatation catheter designed to treat femoropopliteal artery stenoses or occlusive lesions. Sponsored by BrosMed Medical Co., Ltd, this upcoming study will serve as a post-market evaluation of the device, which utilizes drug-coating technology to enhance outcomes in peripheral arterial interventions.
The trial is listed as ‘Not yet recruiting’ on ClinicalTrials.gov, indicating preparations are still underway. Stakeholders in clinical, regulatory, and quality domains may find this development highly relevant as it could shape future pathways in vascular device approvals and performance benchmarks.
In this article:
- What changed?
- What are the trial objectives?
- What is the device technology?
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What changed?
The announcement of this post-market clinical trial marks a significant step in evaluating innovative drug-coated balloon angioplasty technologies for peripheral artery conditions. BrosMed Medical Co., Ltd, the sponsor of the trial, seeks to gather robust clinical data to support ongoing regulatory compliance and device performance verification.
What are the trial objectives?
The main goals of this trial include:
- Assessing the therapeutic effectiveness of the drug-coated balloon catheter in treating femoropopliteal artery stenoses or occlusive lesions.
- Evaluating safety indicators such as adverse event rates and procedural complications.
- Collecting real-world evidence to support clinical recommendations and future approval processes.
Such data is essential for manufacturers and healthcare professionals seeking to rely on evidence-based methodologies while navigating regulation and performance standards.
What is the device technology?
The drug-coated balloon catheter offers innovative therapeutic application via drug-coated technology, which helps prevent restenosis (the recurrence of arterial narrowing) after angioplasty. By delivering medication directly to the lesion site during balloon dilatation, clinicians aim to improve vessel patency outcomes.
Drug-coated balloon angioplasty has gained traction in recent years due to its potential benefits compared to traditional stents, especially in challenging peripheral vascular applications where stents may pose risks such as thrombosis or mechanical failure.
FAQ
1. Who can participate in the study?
The detailed inclusion criteria for participation have not yet been announced. Interested parties should monitor updates from BrosMed Medical Co., Ltd or ClinicalTrials.gov.
2. Who is the sponsor?
The trial sponsor is BrosMed Medical Co., Ltd, an organization specializing in developing vascular interventional devices.
3. When will recruitment start?
As of October 2025, the trial status indicates ‘Not yet recruiting.’ The specific timeline for subject enrollment will likely be updated soon.
Conclusion
This post-market study represents critical progress in the ongoing effort to optimize treatment for peripheral arterial disease using advanced medical device technologies. Clinical, quality, and regulatory teams should monitor this trial closely for updates that may affect vascular intervention practices and device market considerations.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Healthcare professionals and regulatory teams should consult official trial sources and regulatory authorities for detailed guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07187128?term=medical+device