Genoss DES Prospective Multicenter Registry
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Device-oriented composite end point (TLF) [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
- Patient-oriented composite end point [12 months]
Composite of any death, any myocardial infarction, and any revascularization
- 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]
- Any revascularization [12 months]
- Clinically indicated target-lesion revascularization [12 months]
- Clinically indicated target-vessel revascularization [12 months]
- ARC defined stent thrombosis [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is ≥ 19 years
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Subject implanted Genoss DES within 1 month
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Subject has signed informed consent for data release
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Subject is geographically stable and willing to participate at all follow-up assessments
Exclusion Criteria:
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Subject did not sign informed consent for data release
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Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
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Pregnancy
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Subject with life expectancy less than 12 months
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Subject with cardiogenic shock
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Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
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Currently participating in another study and primary endpoint is not reached yet.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wonju Severance Christian Hospital | Wonju | Gangwon | Korea, Republic of | 220060 |
Sponsors and Collaborators
- Young Jin Youn, MD, PhD
- Genoss Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Yonsei University