NCT03507205

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

9.6 years

First QC Date

April 15, 2018

Last Update Submit

April 22, 2026

Conditions

Keywords

EverolimusSirolimusZotarolimusBiolimusDrug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization

    36 months

Secondary Outcomes (9)

  • Patient-oriented composite outcome

    36 months

  • All-cause death

    36 months

  • Cardiac death

    36 months

  • All-cause myocardial infarction

    36 months

  • Target-vessel myocardial infarction

    36 months

  • +4 more secondary outcomes

Study Arms (5)

HOST-BIOLIMUS-Korea-3000

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

Device: Biomatrix; Biomatrix Flex; Nobori

EXCELLENT-PRIME

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

Device: Xience Prime

EXCELLENT Prospective cohort

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

Device: Xience V/Promus; Cypher

HOST-RESOLINTE

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

Device: DP-ZES-RI

RESOLUTE-Korea

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

Device: Endeavor; Resolute

Interventions

Biodegradable polymer-coated biolimus-eluting stents

Also known as: BP-BES
HOST-BIOLIMUS-Korea-3000

Durable polymer-coated everolimus-eluting stents

Also known as: DP-EES-Prime
EXCELLENT-PRIME
DP-ZES-RIDEVICE

Durable polymer-coated zotarolimus-eluting stents

Also known as: Resolute Integrity
HOST-RESOLINTE

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

Also known as: DP-EES; SES
EXCELLENT Prospective cohort

Durable polymer-coated zotarolimus-eluting stents

Also known as: DP-ZES
RESOLUTE-Korea

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 17,286 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Location

Sejong General Hospital

Bucheon-si, Gyeonggi-do, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gwangju Christian Hospital

Gwangju, South Korea

Location

Kwangju Veterans Hospital

Gwangju, South Korea

Location

Chonbuk National University Hospital

Iksan, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Ilsan, South Korea

Location

Inha University Hospital

Inchon, South Korea

Location

Chungbuk National University Hospital

Jeonju, South Korea

Location

Presbyterian Medical Center

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Bundang CHA Medical Center

Seongnam, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Ewha Womans University Medical Center Mokdong Hospital

Seoul, South Korea

Location

Gangbuk Samsung Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Boramae Hospital

Seoul, South Korea

Location

Soonchunhyang University Hospital

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

St. Carollo Hospital

Suncheon, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Related Publications (6)

  • Lee HS, Park KW, Kang J, Ki YJ, Chang M, Han JK, Yang HM, Kang HJ, Koo BK, Kim HS. Sarcopenia Index as a Predictor of Clinical Outcomes in Older Patients with Coronary Artery Disease. J Clin Med. 2020 Sep 27;9(10):3121. doi: 10.3390/jcm9103121.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hyo-Soo Kim, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 15, 2018

First Posted

April 24, 2018

Study Start

April 1, 2008

Primary Completion

November 1, 2017

Study Completion

November 30, 2017

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations