Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

Completed

• Conditions: Coronary Artery Disease

• 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.

Study Timeline

• Study Start: 2008-04-01
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Last Update Submitted: 2018-04-15
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17286

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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
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
Clinically-driven target vessel revascularization	36 months	Clinically-driven target vessel revascularization

Trial Locations

Locations (37)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

Sejong General Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, 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

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