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Coronary Artery DiseaseGrand-DESNCT03507205

Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 37 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
What is being tested?
Biomatrix; Biomatrix Flex; Nobori, Xience Prime and Xience V/Promus; Cypher
Type of treatment
Medical device
How many people
17,286 participants
Where
37 sitesSouth Korea
Study dates
1 Apr 2008to 30 Nov 2017
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • There are no exclusion criteria for this registry.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

South Korea37 sites

  • Hallym University Sacred Heart Hospital

    Anyang

  • Sejong General Hospital

    Bucheon-si, Gyeonggi-do

  • Kosin University Gospel Hospital

    Busan

  • Dankook University Hospital

    Cheonan

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

  • Chungnam National University Hospital

    Daejeon

  • Chonnam National University Hospital

    Gwangju

  • Gwangju Christian Hospital

    Gwangju

  • Kwangju Veterans Hospital

    Gwangju

  • Chonbuk National University Hospital

    Iksan

  • Wonkwang University Hospital

    Iksan

  • Inje University Ilsan Paik Hospital

    Ilsan

  • National Health Insurance Corporation Ilsan Hospital

    Ilsan

  • Inha University Hospital

    Inchon

  • Chungbuk National University Hospital

    Jeonju

  • Presbyterian Medical Center

    Jeonju

  • Gyeongsang National University Hospital

    Jinju

  • Inje University Pusan Paik Hospital

    Pusan

  • Pusan National University Hospital

    Pusan

  • Bundang CHA Medical Center

    Seongnam

  • Seoul National University Bundang Hospital

    Seongnam

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

  • Ewha Womans University Medical Center Mokdong Hospital

    Seoul

  • Gangbuk Samsung Hospital

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul

  • Hanyang University Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • Kyung Hee University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul Boramae Hospital

    Seoul

  • Soonchunhyang University Hospital

    Seoul

  • Yonsei University Medical Center

    Seoul

  • St. Carollo Hospital

    Suncheon

  • Uijeongbu St. Mary's Hospital

    Uijeongbu-si

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do

Other trials in South Korea

About this study

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).

Read the 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.

Being tested
Biomatrix; Biomatrix Flex; Nobori, Xience Prime, Xience V/Promus; Cypher, DP-ZES-RI, Endeavor; Resolute
Keywords
Everolimus, Sirolimus, Zotarolimus, Biolimus, Drug-eluting stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biomatrix; Biomatrix Flex; NoboriDevice

    Also called BP-BES

    Biodegradable polymer-coated biolimus-eluting stents

  • Xience PrimeDevice

    Also called DP-EES-Prime

    Durable polymer-coated everolimus-eluting stents

  • Xience V/Promus; CypherDevice

    Also called DP-EES; SES

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

  • DP-ZES-RIDevice

    Also called Resolute Integrity

    Durable polymer-coated zotarolimus-eluting stents

  • Endeavor; ResoluteDevice

    Also called DP-ZES

    Durable polymer-coated zotarolimus-eluting stents

Study groups in NCT03507205
Study groupRoleWhat they receive
HOST-BIOLIMUS-Korea-3000Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori)
Receives: Device: Biomatrix; Biomatrix Flex; Nobori
EXCELLENT-PRIMEActive prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)
Receives: Device: Xience Prime
EXCELLENT Prospective cohortActive prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher)
Receives: Device: Xience V/Promus; Cypher
HOST-RESOLINTEActive prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)
Receives: Device: DP-ZES-RI
RESOLUTE-KoreaActive prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)
Receives: Device: Endeavor; Resolute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion failure

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

    Measured: 36 months

Secondary outcomes (9)

  1. Patient-oriented composite outcome

    A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization

    Measured: 36 months

  2. All-cause death

    All-cause death

    Measured: 36 months

  3. Cardiac death

    Cardiac death

    Measured: 36 months

  4. All-cause myocardial infarction

    All-cause myocardial infarction

    Measured: 36 months

  5. Target-vessel myocardial infarction

    Target-vessel myocardial infarction

    Measured: 36 months

  6. Any repeat revascularization

    Any repeat revascularization

    Measured: 36 months

  7. Clinically-driven target vessel revascularization

    Clinically-driven target vessel revascularization

    Measured: 36 months

  8. Clinically-driven target lesion revascularization

    Clinically-driven target lesion revascularization

    Measured: 36 months

  9. Definite or probable stent thrombosis

    Definite or probable stent thrombosis

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2018
  2. Study start1 Apr 2008
  3. Primary completion1 Nov 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17,286 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507205
Sponsor's protocol ID
Grand-DES
Acronym
Grand-DES
Status last verified
Apr 2026
First submitted
15 Apr 2018
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32992530

  • 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.

    PubMed 35491482

  • 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.

    PubMed 35439958

  • 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.

    PubMed 33817960

  • 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.

    PubMed 33541106

  • 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.

    PubMed 32224030

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 37 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507205, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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