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Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels - Trial NCT06345209

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.

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ClinicalTrials.gov • NCT06345209
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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.

Study Focus

Coronary Artery Disease

Sirolimus-coated Coronary Balloon Dilatation Catheter

Interventional

device

Sponsor & Location

BrosMed Medical Co., Ltd

Timeline & Enrollment

N/A

May 01, 2024

Dec 01, 2025

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, unspecified
Atherosclerotic cardiovascular disease, so described
Atherosclerotic heart disease
Abnormal findings on diagnostic imaging of heart and coronary circulation
Coronary vasodilators, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06345209

Device Trial