NCT03045913

Brief Summary

This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

January 23, 2017

Last Update Submit

January 27, 2023

Conditions

Coronary Artery DiseaseMyocardial IschemiaMyocardial Infarction

Keywords

Observational registryAll-comers open label registryGenoss DESMulticenterStentingCoronary Artery DiseaseCoronary revascularizationPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Device-oriented composite end point (TLF)

    Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization

    12 months

Secondary Outcomes (9)

  • Patient-oriented composite end point

    12 months

  • Cardiac death

    12 months

  • Non-cardiac death

    12 months

  • Any myocardial infarction

    12 months

  • Any myocardial infarction not clearly attributable to a nontarget vessel

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Genoss DES

Subject implanted Genoss DES for coronary artery disease

Device: Genoss DES

Interventions

Genoss DESDEVICE

The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Genoss DES

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

You may qualify if:

  • Subject is ≥ 19 years
  • Subject implanted Genoss DES within 1 month
  • Subject has signed informed consent for data release
  • Subject is geographically stable and willing to participate at all follow-up assessments

You may not qualify if:

  • Subject did not sign informed consent for data release
  • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
  • Pregnancy
  • Subject with life expectancy less than 12 months
  • Subject with cardiogenic shock
  • Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not reached yet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk, South Korea

Location

Dankook University Hospital

Cheonan, Chungcheongnam, South Korea

Location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Location

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Location

Gangneung Asan Hospital

Gangneung, Gangwon-do, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 220060, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

Myongji Hospital, Hanyang University College of Medicine

Goyang-si, Gyeonggi-do, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Severance Cardiovascular Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Junghan Yoon, MD, PhD

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 8, 2017

Study Start

November 18, 2016

Primary Completion

November 29, 2021

Study Completion

December 31, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(17)