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

Sponsor

CGBio Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03089450

Collaborator

(none)

112

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Stable Coronary Artery Disease Stable Angina Unstable Angina NSTEMI - Non-ST Segment Elevation MI	Device: CGBio stent Device: Biomatrix flex	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 22, 2017

Anticipated Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CGBIO stent (DES) The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)	Device: CGBio stent Percutaneous Coronary Intervention
Active Comparator: Biomatrix flex(DES) The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG	Device: Biomatrix flex Percutaneous Coronary Intervention

Arm

Intervention/Treatment

Experimental: CGBIO stent (DES)

The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)

Device: CGBio stent

Percutaneous Coronary Intervention

Active Comparator: Biomatrix flex(DES)

The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG

Device: Biomatrix flex

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcome Measures

in-segment late loss [9 month]
angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soeul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

CGBio Inc.

Investigators

Study Chair: Hyo-Soo KIim, MD/PhD, Soeoul national university hospital
Principal Investigator: Young-Hyo Lim, MD/PhD, Hanyang University
Principal Investigator: Junghan Yoon, MD/PhD, Wonju Severance Christian Hospital