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NCT06385067

Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter

Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
JW Medical Systems Ltd·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Coronary Artery Disease
Drug/Device/Intervention
Biolimus Coated Coronary Artery Balloon Dilation Catheter
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
JW Medical Systems Ltd
Timeline & enrollment
Phase
N/A
Start date
May 10, 2024
End date
Dec 30, 2026
Enrollment
400 participants
Primary outcome

Target lesion failure rate (TLF)

Summary

The purpose of the study was to further evaluate the long-term safety and efficacy of the
 Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.
 
 The study population was patients with primary coronary vascular lesions with a blood vessel
 diameter of 2.0mm-2.75mm.

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
NCT06385067
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06385067 through Pure Global AI's free database. This phase not specified trial is sponsored by JW Medical Systems Ltd and is currently Not yet recruiting. The study focuses on Coronary Artery Disease. Target enrollment is 400 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.