Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents (Grand-DES)

Seoul National University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Xience Prime; Device: Biomatrix; Biomatrix Flex; Nobori; Device: Xience V/Promus; Cypher; Device: Endeavor; Resolute; Device: DP-ZES-RI

Study type: Observational

Funder types: Other

Identifiers

NCT03507205

Grand-DES

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17,286 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

17,286 participants in 5 patient groups

HOST-BIOLIMUS-Korea-3000

Description:

Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori)

Treatment:

Device: Biomatrix; Biomatrix Flex; Nobori

EXCELLENT-PRIME

Description:

Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)

Treatment:

Device: Xience Prime

EXCELLENT Prospective cohort

Description:

Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher)

Treatment:

Device: Xience V/Promus; Cypher

HOST-RESOLINTE

Description:

Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)

Treatment:

Device: DP-ZES-RI

RESOLUTE-Korea

Description:

Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)

Treatment:

Device: Endeavor; Resolute