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Genoss DES Prospective Multicenter Registry

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ClinicalTrials.gov Identifier: NCT03045913
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Genoss Co., Ltd.
Information provided by (Responsible Party):
Yoon Junghan, Yonsei University

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

Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Ischemia Myocardial Infarction Device: Genoss DES

Detailed Description:

Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.

Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.

This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Genoss DES
Subject implanted Genoss DES for coronary artery disease
Device: Genoss DES
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.




Primary Outcome Measures :
  1. Device-oriented composite end point (TLF) [ Time Frame: 12 months ]
    Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization


Secondary Outcome Measures :
  1. Patient-oriented composite end point [ Time Frame: 12 months ]
    Composite of any death, any myocardial infarction, and any revascularization

  2. Cardiac death [ Time Frame: 12 months ]
  3. Non-cardiac death [ Time Frame: 12 months ]
  4. Any myocardial infarction [ Time Frame: 12 months ]
  5. Any myocardial infarction not clearly attributable to a nontarget vessel [ Time Frame: 12 months ]
  6. Any revascularization [ Time Frame: 12 months ]
  7. Clinically indicated target-lesion revascularization [ Time Frame: 12 months ]
  8. Clinically indicated target-vessel revascularization [ Time Frame: 12 months ]
  9. ARC defined stent thrombosis [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045913


Contacts
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Contact: Junghan Yoon, MD, PhD +82-33-741-1219 jyoon@yonsei.ac.kr
Contact: Young Jin Yoon, MD +82-33-741-1219 younyj@yonsei.ac.kr

Locations
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Korea, Republic of
Wonju Severance Christian Hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 220060
Contact: Junghan Yoon, MD, PhD    +82-33-741-0906    jyoon@yonsei.ac.kr   
Principal Investigator: Young Jin Youn, MD         
Sub-Investigator: Junghan Yoon, MD, PhD         
Sub-Investigator: Seung-Hwan Lee, MD, PhD         
Sub-Investigator: Byung-Su Yoo, MD, PhD         
Sub-Investigator: Jang-Young Kim, MD, PhD         
Sub-Investigator: Min-Soo Ahn, MD         
Sub-Investigator: Sung-Gyun Ahn, MD         
Sub-Investigator: Ji-Hyun Lee, MD         
Sub-Investigator: Woo-Cheol Kwon, MD, PhD         
Sponsors and Collaborators
Yoon Junghan
Genoss Co., Ltd.

Additional Information:

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Responsible Party: Yoon Junghan, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT03045913    
Other Study ID Numbers: Yonsei University
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yoon Junghan, Yonsei University:
Observational registry
All-comers open label registry
Genoss DES
Multicenter
Stenting
Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs