Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Biomatrix; Biomatrix Flex; NoboriDevice: Xience V/Promus; CypherDevice: DP-ZES-RIDevice: Endeavor; ResoluteDevice: Xience Prime
- Registration Number
- NCT03507205
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world.
The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).
- Detailed Description
The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17286
- The patient agrees to participate in this study by signing the informed consent form.
- Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
- There are no exclusion criteria for this registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HOST-BIOLIMUS-Korea-3000 Biomatrix; Biomatrix Flex; Nobori Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori) EXCELLENT Prospective cohort Xience V/Promus; Cypher Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher) HOST-RESOLINTE DP-ZES-RI Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity) RESOLUTE-Korea Endeavor; Resolute Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute) EXCELLENT-PRIME Xience Prime Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)
- Primary Outcome Measures
Name Time Method Target lesion failure 36 months A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization
- Secondary Outcome Measures
Name Time Method Clinically-driven target vessel revascularization 36 months Clinically-driven target vessel revascularization
All-cause myocardial infarction 36 months All-cause myocardial infarction
Cardiac death 36 months Cardiac death
Clinically-driven target lesion revascularization 36 months Clinically-driven target lesion revascularization
Definite or probable stent thrombosis 36 months Definite or probable stent thrombosis
Patient-oriented composite outcome 36 months A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization
All-cause death 36 months All-cause death
Any repeat revascularization 36 months Any repeat revascularization
Target-vessel myocardial infarction 36 months Target-vessel myocardial infarction
Trial Locations
- Locations (37)
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Kwangju Veterans Hospital
🇰🇷Gwangju, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Seoul Boramae Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Medical Center Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Iksan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Bundang CHA Medical Center
🇰🇷Seongnam, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Gangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Gwangju Christian Hospital
🇰🇷Gwangju, Korea, Republic of