ClinicalTrials.gg
Status unknownNCT03089450Updated Mar 28, 2017

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

An interventional study of CGBio stent and Biomatrix flex in Ischemic Heart Disease, Stable Coronary Artery Disease and Stable Angina, sponsored by CGBio Inc.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by CGBio Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 61 studies in Myocardial Ischemia with a site in Korea, Republic of — 13 open to participants now, 17 under way, none of them phase 3. Myocardial Ischemia · Korea, Republic of.

Planned enrollment
21st of 30
112 · median 209
Started
2017
with 3 others
No phase
19 of 61
6 open now
Registered
32nd of 61
by date

Among the 61 studies in Myocardial Ischemia with a site in Korea, Republic of, this one is the 21st largest by planned enrollment of the 30 interventional ones that give a count, is one of 4 that started in 2017, is one of 19 with no phase, and was the 32nd registered.

Myocardial Ischemia

1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.

Browse Myocardial Ischemia studies →

Open to participants now

13 of the 61 studies in Myocardial Ischemia with a site in Korea, Republic of are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.

This study: 20 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 61 studies in Myocardial Ischemia with a site in Korea, Republic of, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Ischemic Heart Disease
  • Stable Coronary Artery Disease
  • Stable Angina
  • Unstable Angina
  • NSTEMI - Non-ST Segment Elevation MI
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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- and/or anticoagulant therapy is 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    CGBIO stent (DES)

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

    Device: CGBio stent

  • Active comparator
    Biomatrix flex(DES)

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

    Device: Biomatrix flex

Interventions

  • DeviceCGBio stent

    Percutaneous Coronary Intervention

  • DeviceBiomatrix flex

    Percutaneous Coronary Intervention

06

What researchers measure

Primary outcomes

  1. in-segment late loss

    angiographic in-segment late loss measure by QCA program

    Time frame: 9 month

Secondary outcomes

  1. in-stent late loss

    angiographic in-stent late loss measure by QCA program

    Time frame: 9 month

  2. MACE

    death, MI and TVF

    Time frame: 9 month

  3. Restenosis rate

    angiographic restenosis rate

    Time frame: 9month

07

Study locations

1 of 1 sites recruiting
  • Soeul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Sep 2017, 6 months after the start.

Of 37 industry-sponsored interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 6 months is below that.

Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2017
First posted
Mar 24, 2017
StartActual
Mar 22, 2017
Primary completionEst.
Sep 2017
CompletionEst.
Jun 2018
Last update
Mar 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03089450
Lead sponsor
CGBio Inc.
Responsible party
Sponsor
First posted
Mar 24, 2017
Start date
Mar 22, 2017
Primary completion
Sep 2017 (estimated)
Completion
Jun 2018 (estimated)
Last update
Mar 28, 2017

Study contacts

Hyo-Soo KIim, MD/PhD
Contact
usahyosoo@gmail.com
+82-2-2072-2226
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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