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Clinical Trial 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.


Clinical Trial Description

The investigation is a prospective, multi-center, randomized control, non-inferiority clinical study. The study will be conducted in up to 8 investigational sites in the China This study will enroll and treat 136 subjects, including in-stent restenosis (ISR). The population for this study is subjects with stenotic coronary artery disease who are suitable candidates for PTCA. After screening for initial inclusion and exclusion criteria, eligible subjects will be asked to participate in the study by signing a consent form. Following consent, subjects will undergo a baseline visit where eligibility criteria will be assessed. Then, subjects will be randomized to either trial balloon (Sino Medical Sciences Technology Inc. ) or to a NSE Coronary Dilatation Catheter (Goodman Co.,Ltd). Angiograms will be performed before and after intervention. Subjects will be followed through hospital discharge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05509296
Study type Interventional
Source Sino Medical Sciences Technology Inc.
Contact
Status Completed
Phase N/A
Start date September 20, 2022
Completion date November 23, 2022

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