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NCT06345209

Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels

A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter for the Treatment of De Novo Coronary Artery Small Vessel Lesions.
BrosMed Medical Co., Ltd·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Coronary Artery Disease
Drug/Device/Intervention
Sirolimus-coated Coronary Balloon Dilatation Catheter
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
BrosMed Medical Co., Ltd
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Dec 01, 2025
Enrollment
236 participants
Primary outcome

Late luminal loss (LLL)

Summary

To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation
 catheter for the treatment of small vessel lesions of primary coronary arteries.

ICD-10 classifications
Cardiovascular disease, unspecifiedAtherosclerotic cardiovascular disease, so describedAtherosclerotic heart diseaseAbnormal findings on diagnostic imaging of heart and coronary circulationCoronary vasodilators, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06345209
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06345209 through Pure Global AI's free database. This phase not specified trial is sponsored by BrosMed Medical Co., Ltd and is currently Not yet recruiting. The study focuses on Coronary Artery Disease. Target enrollment is 236 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.