- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507205
Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents (Grand-DES)
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).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Anyang, South Korea
- Hallym University Sacred Heart Hospital
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Busan, South Korea
- Kosin University Gospel Hospital
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Cheonan, South Korea
- Soon Chun Hyang University Hospital Cheonan
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Cheonan, South Korea
- Dankook University Hospital
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Daejeon, South Korea
- Chungnam National University Hospital
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Gwangju, South Korea
- Chonnam National University Hospital
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Gwangju, South Korea
- Gwangju Christian Hospital
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Gwangju, South Korea
- Kwangju Veterans Hospital
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Iksan, South Korea
- Wonkwang University Hospital
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Iksan, South Korea
- Chonbuk National University Hospital
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Ilsan, South Korea
- Inje University Ilsan Paik Hospital
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Ilsan, South Korea
- National Health Insurance Corporation Ilsan Hospital
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Inchon, South Korea
- Inha University Hospital
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Jeonju, South Korea
- Presbyterian Medical Center
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Jeonju, South Korea
- Chungbuk National University Hospital
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Jinju, South Korea
- Gyeongsang National University Hospital
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Pusan, South Korea
- Inje University Pusan Paik Hospital
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Pusan, South Korea
- Pusan National University Hospital
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Seongnam, South Korea
- Seoul National University Bundang Hospital
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Seongnam, South Korea
- Bundang CHA Medical Center
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Seoul, South Korea
- Korea University Guro Hospital
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Seoul, South Korea
- Samsung Medical Center
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Seoul, South Korea
- Gangnam Severance Hospital
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Seoul, South Korea
- Kyung Hee University Medical Center
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Seoul, South Korea
- Hanyang University Medical Center
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Seoul, South Korea
- Seoul Boramae Hospital
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Seoul, South Korea
- Kyung Hee University Hospital at Gangdong
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Seoul, South Korea
- Yonsei University Medical Center
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Seoul, South Korea
- Soonchunhyang University Hospital
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Seoul, South Korea
- Ewha Womans University Medical Center Mokdong Hospital
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Seoul, South Korea
- Gangbuk Samsung Hospital
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Seoul, South Korea
- Hallym University Kangdong Sacred Heart Hospital
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Suncheon, South Korea
- St. Carollo Hospital
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Uijeongbu-si, South Korea
- Uijeongbu St. Mary's Hospital
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Gangwon-do
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Wŏnju, Gangwon-do, South Korea
- Wonju Severance Christian Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, South Korea
- Sejong General Hospital
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Jongno-gu
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Seoul, Jongno-gu, South Korea, 03080
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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HOST-BIOLIMUS-Korea-3000
Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori)
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Biodegradable polymer-coated biolimus-eluting stents
Other Names:
|
|
EXCELLENT-PRIME
Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)
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Durable polymer-coated everolimus-eluting stents
Other Names:
|
|
EXCELLENT Prospective cohort
Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher)
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Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
Other Names:
|
|
HOST-RESOLINTE
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)
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Durable polymer-coated zotarolimus-eluting stents
Other Names:
|
|
RESOLUTE-Korea
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)
|
Durable polymer-coated zotarolimus-eluting stents
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Target lesion failure
Time Frame: 36 months
|
A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-oriented composite outcome
Time Frame: 36 months
|
A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization
|
36 months
|
|
All-cause death
Time Frame: 36 months
|
All-cause death
|
36 months
|
|
Cardiac death
Time Frame: 36 months
|
Cardiac death
|
36 months
|
|
All-cause myocardial infarction
Time Frame: 36 months
|
All-cause myocardial infarction
|
36 months
|
|
Target-vessel myocardial infarction
Time Frame: 36 months
|
Target-vessel myocardial infarction
|
36 months
|
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Any repeat revascularization
Time Frame: 36 months
|
Any repeat revascularization
|
36 months
|
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Clinically-driven target vessel revascularization
Time Frame: 36 months
|
Clinically-driven target vessel revascularization
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36 months
|
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Clinically-driven target lesion revascularization
Time Frame: 36 months
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Clinically-driven target lesion revascularization
|
36 months
|
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Definite or probable stent thrombosis
Time Frame: 36 months
|
Definite or probable stent thrombosis
|
36 months
|
Collaborators and Investigators
Investigators
- Study Chair: Hyo-Soo Kim, MD, PhD, Seoul National University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grand-DES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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