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

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ClinicalTrials.gov Identifier: NCT03507205
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

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).


Condition or disease Intervention/treatment
Coronary Artery Disease Device: Biomatrix; Biomatrix Flex; Nobori Device: Xience Prime Device: Xience V/Promus; Cypher Device: DP-ZES-RI Device: Endeavor; Resolute

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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 17286 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents
Actual Study Start Date : April 1, 2008
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 30, 2017

Group/Cohort Intervention/treatment
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
Biodegradable polymer-coated biolimus-eluting stents
Other Name: BP-BES
EXCELLENT-PRIME
Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime)
Device: Xience Prime
Durable polymer-coated everolimus-eluting stents
Other Name: DP-EES-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
Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
Other Name: DP-EES; SES
HOST-RESOLINTE
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity)
Device: DP-ZES-RI
Durable polymer-coated zotarolimus-eluting stents
Other Name: Resolute Integrity
RESOLUTE-Korea
Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute)
Device: Endeavor; Resolute
Durable polymer-coated zotarolimus-eluting stents
Other Name: DP-ZES



Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 36 months ]
    A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization


Secondary Outcome Measures :
  1. Patient-oriented composite outcome [ Time Frame: 36 months ]
    A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization

  2. All-cause death [ Time Frame: 36 months ]
    All-cause death

  3. Cardiac death [ Time Frame: 36 months ]
    Cardiac death

  4. All-cause myocardial infarction [ Time Frame: 36 months ]
    All-cause myocardial infarction

  5. Target-vessel myocardial infarction [ Time Frame: 36 months ]
    Target-vessel myocardial infarction

  6. Any repeat revascularization [ Time Frame: 36 months ]
    Any repeat revascularization

  7. Clinically-driven target vessel revascularization [ Time Frame: 36 months ]
    Clinically-driven target vessel revascularization

  8. Clinically-driven target lesion revascularization [ Time Frame: 36 months ]
    Clinically-driven target lesion revascularization

  9. Definite or probable stent thrombosis [ Time Frame: 36 months ]
    Definite or probable stent thrombosis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507205


Locations
Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Gangwon-do, Korea, Republic of
Sejong General Hospital
Bucheon, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 03080
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Kosin University Gospel Hospital
Busan, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
Cheonan, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gwangju Christian Hospital
Gwangju, Korea, Republic of
Kwangju Veterans Hospital
Gwangju, Korea, Republic of
Chonbuk National University Hospital
Iksan, Korea, Republic of
Wonkwang University Hospital
Iksan, Korea, Republic of
Inje University Ilsan Paik Hospital
Ilsan, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Ilsan, Korea, Republic of
Inha University Hospital
Inchon, Korea, Republic of
Chungbuk National University Hospital
Jeonju, Korea, Republic of
Presbyterian Medical Center
Jeonju, Korea, Republic of
Gyeongsang National University Hospital
Jinju, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Bundang CHA Medical Center
Seongnam, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Ewha Womans University Medical Center Mokdong Hospital
Seoul, Korea, Republic of
Gangbuk Samsung Hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul Boramae Hospital
Seoul, Korea, Republic of
Soonchunhyang University Hospital
Seoul, Korea, Republic of
Yonsei University Medical Center
Seoul, Korea, Republic of
St. Carollo Hospital
Suncheon, Korea, Republic of
Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital

Responsible Party: Hyo-Soo Kim, Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03507205     History of Changes
Other Study ID Numbers: Grand-DES
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
Everolimus
Sirolimus
Zotarolimus
Biolimus
Drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents