Ischemic Heart DiseaseNCT03089450
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
A study testing CGBio stent and Biomatrix flex in people with Ischemic Heart Disease and Stable Coronary Artery Disease, run by CGBio Inc. at 1 site in South Korea.
Trial summary
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES) Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina
- What is being tested?
- CGBio stent and Biomatrix flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soeul National University Hospital
Seoul
Hyo-Soo Kim, MD/PhD, +82-2-2072-2226, usahyosoo@gmail.com
Eunkyung Lee, +82 2-2072-4034, yordim.lee@gmail.com
About this study
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
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
Read the 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
- Conditions
- Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- CGBio stent, Biomatrix flex
- Medical subject headings
- Myocardial Ischemia, Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGBio stentDevice
Percutaneous Coronary Intervention
Biomatrix flexDevice
Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| CGBIO stent (DES) | Experimental | The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C) Receives: Device: CGBio stent |
| Biomatrix flex(DES) | Active comparator | The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG Receives: Device: Biomatrix flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-segment late loss
angiographic in-segment late loss measure by QCA program
Measured: 9 month
Secondary outcomes (3)
in-stent late loss
angiographic in-stent late loss measure by QCA program
Measured: 9 month
MACE
death, MI and TVF
Measured: 9 month
Restenosis rate
angiographic restenosis rate
Measured: 9month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start22 Mar 2017
- Primary completionSep 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CGBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo-Soo KIim, MD/PhD, Study chair, Soeoul national university hospitalYoung-Hyo Lim, MD/PhD, Principal investigator, Hanyang UniversityJunghan Yoon, MD/PhD, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089450
- Sponsor's protocol ID
- CG-DE-225-008
- Status last verified
- Mar 2017
- First submitted
- 19 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03089450
- Acronym / sponsor ID
- CG-DE-225-008
- Conditions
- Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- CGBio Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGBIO stent (DES) | Experimental | Device: CGBio stentThe Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C) |
| Biomatrix flex(DES) | Active comparator | Device: Biomatrix flexThe abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- ST-segment elevation MI
- Bifurcation lesion
- Chronic total occulusion
- Restenosis lesion
- Graft vessel lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGBio stentPercutaneous Coronary Intervention | Device | CGBIO stent (DES) |
| Biomatrix flexPercutaneous Coronary Intervention | Device | Biomatrix flex(DES) |
Primary outcome
in-segment late loss
Time frame: 9 month
angiographic in-segment late loss measure by QCA program
3 secondary outcomes
in-stent late loss
Time frame: 9 month
MACE
Time frame: 9 month
Restenosis rate
Time frame: 9month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-Soo KIim, MD/PhD study chair
Soeoul national university hospital
Young-Hyo Lim, MD/PhD principal investigator
Hanyang University
Junghan Yoon, MD/PhD principal investigator
Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGBio stent and Biomatrix flex in people with Ischemic Heart Disease and Stable Coronary Artery Disease, run by CGBio Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Soo KIim, MD/PhD (+82-2-2072-2226, usahyosoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-segment late loss (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.