To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
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
1 other identifier
interventional
112
1 country
1
Brief Summary
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2017
CompletedStudy Start
First participant enrolled
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 28, 2017
March 1, 2017
5 months
March 19, 2017
March 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
in-segment late loss
angiographic in-segment late loss measure by QCA program
9 month
Secondary Outcomes (3)
in-stent late loss
9 month
MACE
9 month
Restenosis rate
9month
Study Arms (2)
CGBIO stent (DES)
EXPERIMENTALThe Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)
Biomatrix flex(DES)
ACTIVE COMPARATORThe abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CGBio Inc.lead
Study Sites (1)
Soeul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2017
First Posted
March 24, 2017
Study Start
March 22, 2017
Primary Completion
September 1, 2017
Study Completion
June 1, 2018
Last Updated
March 28, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share