Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

NCT ID: NCT03507205

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

17286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-01

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HOST-BIOLIMUS-Korea-3000

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

Biomatrix; Biomatrix Flex; Nobori

Intervention Type DEVICE

Biodegradable polymer-coated biolimus-eluting stents

EXCELLENT-PRIME

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

Xience Prime

Intervention Type DEVICE

Durable polymer-coated everolimus-eluting stents

EXCELLENT Prospective cohort

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

Xience V/Promus; Cypher

Intervention Type DEVICE

Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents

HOST-RESOLINTE

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

DP-ZES-RI

Intervention Type DEVICE

Durable polymer-coated zotarolimus-eluting stents

RESOLUTE-Korea

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

Endeavor; Resolute

Intervention Type DEVICE

Durable polymer-coated zotarolimus-eluting stents

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biomatrix; Biomatrix Flex; Nobori

Biodegradable polymer-coated biolimus-eluting stents

Intervention Type DEVICE

Xience Prime

Durable polymer-coated everolimus-eluting stents

Intervention Type DEVICE

Xience V/Promus; Cypher

Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents

Intervention Type DEVICE

DP-ZES-RI

Durable polymer-coated zotarolimus-eluting stents

Intervention Type DEVICE

Endeavor; Resolute

Durable polymer-coated zotarolimus-eluting stents

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BP-BES DP-EES-Prime DP-EES; SES Resolute Integrity DP-ZES

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hyo-Soo Kim

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyo-Soo Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Sejong General Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Dankook University Hospital

Cheonan, , South Korea

Site Status

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Gwangju Christian Hospital

Gwangju, , South Korea

Site Status

Kwangju Veterans Hospital

Gwangju, , South Korea

Site Status

Chonbuk National University Hospital

Iksan, , South Korea

Site Status

Wonkwang University Hospital

Iksan, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status

National Health Insurance Corporation Ilsan Hospital

Ilsan, , South Korea

Site Status

Inha University Hospital

Inchon, , South Korea

Site Status

Chungbuk National University Hospital

Jeonju, , South Korea

Site Status

Presbyterian Medical Center

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Bundang CHA Medical Center

Seongnam, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Ewha Womans University Medical Center Mokdong Hospital

Seoul, , South Korea

Site Status

Gangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Hallym University Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

Hanyang University Medical Center

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Kyung Hee University Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul Boramae Hospital

Seoul, , South Korea

Site Status

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Yonsei University Medical Center

Seoul, , South Korea

Site Status

St. Carollo Hospital

Suncheon, , South Korea

Site Status

Uijeongbu St. Mary's Hospital

Uijeongbu-si, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Park J, Han JK, Kang J, Chae IH, Lee SY, Choi YJ, Rhew JY, Rha SW, Shin ES, Woo SI, Lee HC, Chun KJ, Kim D, Jeong JO, Bae JW, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. The Clinical Impact of beta-Blocker Therapy on Patients With Chronic Coronary Artery Disease After Percutaneous Coronary Intervention. Korean Circ J. 2022 Jul;52(7):544-555. doi: 10.4070/kcj.2021.0395. Epub 2022 Apr 4.

Reference Type DERIVED
PMID: 35491482 (View on PubMed)

Hwang D, Park J, Yang HM, Yang S, Kang J, Han JK, Park KW, Kang HJ, Koo BK, Kim HS. Angiographic complete revascularization versus incomplete revascularization in patients with diabetes mellitus. Cardiovasc Diabetol. 2022 Apr 19;21(1):56. doi: 10.1186/s12933-022-01488-7.

Reference Type DERIVED
PMID: 35439958 (View on PubMed)

Kim M, Park KW, Lee HS, Ki YJ, Kang J, Kim CH, Han JK, Yang HM, Kang HJ, Koo BK, Kim HS. The validation of the dual antiplatelet therapy score in East Asians receiving percutaneous coronary intervention with exclusively second generation drug-eluting stents. Catheter Cardiovasc Interv. 2021 Sep;98(3):E332-E341. doi: 10.1002/ccd.29682. Epub 2021 Apr 5.

Reference Type DERIVED
PMID: 33817960 (View on PubMed)

Kang J, Park KW, Lee HS, Zheng C, Rhee TM, Ki YJ, Chang M, Han JK, Yang HM, Kang HJ, Koo BK, Kim HS. Relative Impact of Clinical Risk Versus Procedural Risk on Clinical Outcomes After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 Feb;14(2):e009642. doi: 10.1161/CIRCINTERVENTIONS.120.009642. Epub 2021 Feb 5.

Reference Type DERIVED
PMID: 33541106 (View on PubMed)

Zheng C, Kang J, Yang HM, Han JK, Park KW, Kang HJ, Koo BK, Kim HS. Safety and Efficacy of Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Myocardial Infarction in the Presence of Intracoronary Thrombus: An Analysis From the Grand Drug-eluting Stent Registry. Clin Ther. 2020 May;42(5):954-958.e6. doi: 10.1016/j.clinthera.2020.02.022. Epub 2020 Mar 26.

Reference Type DERIVED
PMID: 32224030 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Grand-DES

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CONNECT DES Registrty
NCT04715594 UNKNOWN
GENOSS Coronary Stent Clinical Trial
NCT05444452 RECRUITING NA