NCT05509296

Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Sino Medical Sciences Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Stenosis
• Coronary Artery Stenosis
• In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	SINOMED CBC	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.
DEVICE	NSE Coronary Dilatation Catheter	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.

Timeline

• Start date: 2022-09-20
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2022-08-22
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

8 sites across 1 country: China