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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03089450
• Other study ID #: CG-DE-225-008
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2017
• Last updated: March 26, 2017
• Start date: March 22, 2017
• Est. completion date: June 2018

Study information

• Verified date: March 2017
• Source: CGBio Inc.
• Contact: Hyo-Soo KIim, MD/PhD
• Phone: +82-2-2072-2226
• Email: usahyosoo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• NSTEMI - Non-ST Segment Elevation MI
• Stable Angina
• Stable Coronary Artery Disease
• Unstable Angina

Intervention

Device:
• CGBio stent
Percutaneous Coronary Intervention
• Biomatrix flex
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Korea, Republic of	Soeul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CGBio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-segment late loss	angiographic in-segment late loss measure by QCA program	9 month
Secondary	in-stent late loss	angiographic in-stent late loss measure by QCA program	9 month
Secondary	MACE	death, MI and TVF	9 month
Secondary	Restenosis rate	angiographic restenosis rate	9month