To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent

Not Applicable

• Conditions: Unstable Angina; Stable Coronary Artery Disease; NSTEMI - Non-ST Segment Elevation MI; Ischemic Heart Disease; Stable Angina
• Interventions: Device: CGBio stent; Device: Biomatrix flex

• Registration Number: NCT03089450
• Lead Sponsor: CGBio Inc.

Brief Summary

to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)

Detailed Description

A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-19
• Study First Submitted QC: 2017-03-19
• Study Start: 2017-03-22
• Study First Posted: 2017-03-24
• Last Update Submitted: 2017-03-26
• Last Update Posted: 2017-03-28
• Primary Completion: 2017-09
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• At least one lesion with a diameter stenosis >50%
• suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
• Gr 1 ≤TIMI flow

Exclusion Criteria

• ST-segment elevation MI
• Bifurcation lesion
• Chronic total occulusion
• Restenosis lesion
• Graft vessel lesion
• Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
• Cardiogenic shock or hemodynamic compromise
• Existing impairment in liver and kidney.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGBIO stent (DES)	CGBio stent	The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)
Biomatrix flex(DES)	Biomatrix flex	The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG

Primary Outcome Measures

Name	Time	Method
in-segment late loss	9 month	angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures

Name	Time	Method
in-stent late loss	9 month	angiographic in-stent late loss measure by QCA program
MACE	9 month	death, MI and TVF
Restenosis rate	9month	angiographic restenosis rate

Trial Locations

Locations (1)

Soeul National University Hospital; 🇰🇷 Seoul, Korea, Republic of