CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
SINOMED CBC +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05509296
NCT05509296N/ACompleted
CompareCT.gov

A Prospective, Multicenter, Randomized Control, Non-inferiority to Investigate the Effectiveness and Safety of SINOMED CBC for Endovascular Treatment of Stenotic Coronary Artery Disease

Sino Medical Sciences Technology Inc.·interventional·Posted Aug 22, 2022·Updated Mar 27, 2026

In Brief

A clinical study evaluating SINOMED CBC and NSE Coronary Dilatation Catheter for Coronary Stenosis and 2 related conditions. Completed, enrolled 136 participants across 8 sites.

Detailed Summary

The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
CountriesChina
CollaboratorsPeking University First Hospital

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 22, 2022
Enrollment StartSep 20, 2022
Primary CompletionNov 23, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.9 years ago

Interventions

SINOMED CBCdevice

The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

NSE Coronary Dilatation Catheterdevice

The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.