A clinical trial sponsored by Hospital Universitario La Paz is exploring laser atherectomy as a promising intervention for coronary artery disease, particularly in cases involving calcification, in-stent restenosis, or chronic total occlusion (CTO). As of October 2025, the trial remains active and focuses on situations where conventional methods fail to address undilatable or uncrossable lesions. This study highlights the potential of this medical device innovation.
What is laser atherectomy?
Laser atherectomy is a medical device-enabled procedure designed to clear obstructions in arteries through the use of focused laser energy. By targeting calcified or resistant lesions, this method offers an alternative for cases where established mechanical interventions cannot succeed. The technology facilitates precise removal while minimizing trauma to vessel walls.
What does the study investigate?
The trial specifically addresses challenging coronary artery conditions such as:
- Calcified coronary artery disease
- In-stent restenosis
- Chronic total occlusion (CTO)
Researchers aim to evaluate the performance and safety of laser atherectomy under controlled conditions. Subjects enrolled in the study represent cases that typically resist treatment via conventional catheter-based techniques. Findings could expand therapeutic options for these difficult scenarios.
Device and Sponsor Details
Laser atherectomy systems involved in the study are subject to stringent clinical testing protocols and reporting standards. Hospital Universitario La Paz conducts the trial, ensuring alignment with regulatory norms for medical device trials under the European Medical Device Regulation (MDR).
Study Status and Timelines
As of October 2025, the trial is marked as active but not recruiting, indicating data collection and analysis are underway. Regulatory teams may monitor outcomes for evidence to support future device applications or post-market surveillance.
Implications for clinical practice and regulatory focus
Laser atherectomy trials could reshape treatment protocols for coronary artery disease. Enhanced safety profiles combined with the efficacy in treating resistant lesions may align with new regulatory standards emphasizing personalized approaches and technological advancements. Manufacturers and clinical teams should anticipate potential integration into mainstream guidelines if results showcase superior performance compared to alternatives.
Regulatory experts may also note the emphasis on targeted interventions under MDR Annex XIV, with provisions for safety, intended purpose, and risk-benefit analysis. This trial underscores the importance of meticulous device evaluation in influencing future compliance pathways.
FAQs
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What conditions are treated with laser atherectomy?
Laser atherectomy addresses coronary artery disease conditions like calcified arteries, in-stent restenosis, and chronic total occlusion (CTO). -
Is the trial still recruiting?
No, as of October 2025, the trial is classified as active but is no longer recruiting participants. -
Who sponsors this study?
The study is conducted and sponsored by Hospital Universitario La Paz.
Conclusion
Ongoing research into laser atherectomy emphasizes its potential role in addressing resistant coronary lesions. Professionals in clinical, quality, and regulatory settings should follow updates as findings may influence device approvals and practical guidelines.
Disclaimer
This content is provided for informational purposes only and does not constitute legal or regulatory advice. Always consult subject matter experts before acting on medical device regulatory matters.
Announcement Reference
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07206082?term=medical+device