Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

Coronary Artery Disease Clinical Trial

— Grand-DES  

Official title:

Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507205
• Other study ID #: Grand-DES
• Status: Completed
• First received: April 15, 2018
• Last updated: April 15, 2018
• Start date: April 1, 2008
• Est. completion date: November 30, 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 17286
• Est. completion date: November 30, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• There are no exclusion criteria for this registry.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Biomatrix; Biomatrix Flex; Nobori
Biodegradable polymer-coated biolimus-eluting stents
• Xience Prime
Durable polymer-coated everolimus-eluting stents
• Xience V/Promus; Cypher
Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
• DP-ZES-RI
Durable polymer-coated zotarolimus-eluting stents
• Endeavor; Resolute
Durable polymer-coated zotarolimus-eluting stents

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Sejong General Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gwangju Christian Hospital	Gwangju
Korea, Republic of	Kwangju Veterans Hospital	Gwangju
Korea, Republic of	Chonbuk National University Hospital	Iksan
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	National Health Insurance Corporation Ilsan Hospital	Ilsan
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Chungbuk National University Hospital	Jeonju
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Bundang CHA Medical Center	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Ewha Womans University Medical Center Mokdong Hospital	Seoul
Korea, Republic of	Gangbuk Samsung Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	Yonsei University Medical Center	Seoul
Korea, Republic of	St. Carollo Hospital	Suncheon
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization	36 months
Secondary	Patient-oriented composite outcome	A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization	36 months
Secondary	All-cause death	All-cause death	36 months
Secondary	Cardiac death	Cardiac death	36 months
Secondary	All-cause myocardial infarction	All-cause myocardial infarction	36 months
Secondary	Target-vessel myocardial infarction	Target-vessel myocardial infarction	36 months
Secondary	Any repeat revascularization	Any repeat revascularization	36 months
Secondary	Clinically-driven target vessel revascularization	Clinically-driven target vessel revascularization	36 months
Secondary	Clinically-driven target lesion revascularization	Clinically-driven target lesion revascularization	36 months
Secondary	Definite or probable stent thrombosis	Definite or probable stent thrombosis	36 months