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

March 26, 2017 updated by: CGBio Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-segment late loss
Time Frame: 9 month
angiographic in-segment late loss measure by QCA program
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-stent late loss
Time Frame: 9 month
angiographic in-stent late loss measure by QCA program
9 month
MACE
Time Frame: 9 month
death, MI and TVF
9 month
Restenosis rate
Time Frame: 9month
angiographic restenosis rate
9month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2017

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

March 19, 2017

First Submitted That Met QC Criteria

March 19, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 26, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG-DE-225-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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