Publication Date: October 1, 2025
Beijing Tiantan Hospital is actively recruiting participants for a groundbreaking clinical trial exploring the efficacy and safety of innovative drug-eluting stent systems designed to address symptomatic intracranial atherosclerotic stenosis.
The study, accessible via ClinicalTrials.gov, tests two novel devices: the NxiDIME™ Intracranial Drug-Eluting Stent System and the NOVA DES Intracranial Drug-Eluting Stent.
What changed?
Recent efforts to combat intracranial arterial stenosis have resulted in the development of drug-eluting stents with targeted benefits for patients with symptomatic intracranial atherosclerotic stenosis. This trial seeks to validate these devices’ effectiveness and gauge their safety profiles under clinical conditions.
Hospitals, researchers, and clinical teams invested in managing vascular diseases should monitor the trial’s progress to understand potential advancements in treatment strategies.
About the clinical trial
Sponsored by Beijing Tiantan Hospital, this active clinical trial aims to investigate therapeutic outcomes achieved with two distinct stent systems. Participants will undergo procedure interventions involving either the NxiDIME™ or NOVA DES devices.
Who can participate?
The trial is specifically targeting individuals with diagnosed symptomatic intracranial atherosclerotic stenosis. Details regarding enrollment criteria, geographic site availability, and procedural guidelines can be found on the official ClinicalTrials.gov page.
Device details
The NxiDIME™ Intracranial Drug-Eluting Stent System and the NOVA DES Intracranial Drug-Eluting Stent are innovative devices designed to minimize restenosis while promoting long-term arterial health. Advanced drug-coating technologies aim to reduce the incidence of adverse events commonly linked to intracranial stenting procedures. Manufacturer claims emphasize performance enhancements tailored for targeted pathological conditions.
Safety and performance
The trial prioritizes safety assessment and evaluates performance metrics, including procedural success rates, stent patency, and complication mitigation. Compliance with medical device regulations will ensure adherence to established standards while supporting high-quality data collection.
As intracranial stenting bears procedural risks compared to extra-cranial interventions, the inclusion of drug-eluting technology has sparked optimistic conversations in the medical community.
FAQ
1. What is intracranial arterial stenosis?
Intracranial arterial stenosis refers to narrowing of arteries within the skull caused by a buildup of atherosclerotic plaque, potentially leading to strokes and other complications.
2. How do drug-eluting stents work?
Drug-eluting stents deliver medication directly to the targeted site, reducing restenosis risk while ensuring arterial patency.
Conclusion
This advancement offers a promising pathway for addressing symptomatic intracranial atherosclerotic stenosis using drug-eluting stents. Clinical teams and regulatory stakeholders should observe the outcomes of this trial closely, as they may redefine treatment protocols and improve outcomes for affected patients.
Disclaimer
This article is intended for informational purposes and does not constitute legal or clinical advice. Readers should consult qualified professionals for specific concerns.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07197970?term=medical+device