Clinical trial NCT03045913: Genoss DES Prospective Multicenter Registry
Official title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Myocardial Infarction
Keywords: Observational registry
All-comers open label registry
Genoss DES
Multicenter
Stenting
Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Genoss Co., Ltd.
First posted: 2017-02-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

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

Eligibility 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.

Primary outcomes:
measure: Device-oriented composite end point (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Patient-oriented composite end point
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Non-cardiac death
timeFrame: 12 months
measure: Any myocardial infarction
timeFrame: 12 months
measure: Any myocardial infarction not clearly attributable to a nontarget vessel
timeFrame: 12 months
measure: Any revascularization
timeFrame: 12 months
measure: Clinically indicated target-lesion revascularization
timeFrame: 12 months
measure: Clinically indicated target-vessel revascularization
timeFrame: 12 months
measure: ARC defined stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
state: Gangwon
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital, Hanyang University College of Medicine
state: Gyeonggi
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Junghan Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: