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

NCT ID: NCT03089450

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-22

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Ischemic Heart Disease Stable Coronary Artery Disease Stable Angina Unstable Angina NSTEMI - Non-ST Segment Elevation MI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CGBIO stent (DES)

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

Group Type EXPERIMENTAL

CGBio stent

Intervention Type DEVICE

Percutaneous Coronary Intervention

Biomatrix flex(DES)

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

Group Type ACTIVE_COMPARATOR

Biomatrix flex

Intervention Type DEVICE

Percutaneous Coronary Intervention

Interventions

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CGBio stent

Percutaneous Coronary Intervention

Intervention Type DEVICE

Biomatrix flex

Percutaneous Coronary Intervention

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CGBio Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyo-Soo KIim, MD/PhD

Role: STUDY_CHAIR

Soeoul national university hospital

Young-Hyo Lim, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Junghan Yoon, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hospital

Locations

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Soeul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-Soo KIim, MD/PhD

Role: CONTACT

+82-2-2072-2226

Facility Contacts

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Hyo-Soo Kim, MD/PhD

Role: primary

+82-2-2072-2226

Eunkyung Lee

Role: backup

+82 2-2072-4034

Other Identifiers

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CG-DE-225-008

Identifier Type: -

Identifier Source: org_study_id

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