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SYNERGY Stent in Korean Patients with Acute Coronary Syndrome

Status Approved

  • First Submitted Date

    2021/01/11

  • Registered Date

    2021/03/24

  • Last Updated Date

    2022/04/28

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0006022
    Unique Protocol ID CNUH-2016-241
    Public/Brief Title SYNERGY Stent in Korean Patients with Acute Coronary Syndrome
    Scientific Title SYNERGY Stent in Korean Patients with Acute Coronary Syndrome
    Acronym SAMIR
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2016-241
    Approval Date 2016-09-07
    Institutional Review Board Name Chonnam National University Hospital Institutional review board
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee Yes
    Data and Safety Monitoring Committee

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Myungho Jeong
    Title Professor
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea
    Contact Person for Public Queries
    Name Hyojin Park
    Title Research Nurse
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea
    Contact Person for Updating Information
    Name Hyojin Park
    Title Research Nurse
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 21
    Overall Recruitment Status Terminated
    Date of First Enrollment 2016-10-24 Actual
    Target Number of Participant 960
    Primary Completion Date 2018-10-16 , Actual
    Study Completion Date 2021-10-12 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2016-10-24 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2017-06-07 ,
    Recruitment Status by Participating Study Site 3
    Name of Study The Catholic University of Korea, Bucheon St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-04-14 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Kyung Hee University Hospital at Gangdong
    Recruitment Status Completed
    Date of First Enrollment 2017-10-26 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Kyung Hee University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-12-06 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Kwangju Christian Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-07-06 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2017-07-05 ,
    Recruitment Status by Participating Study Site 8
    Name of Study St. Carollo General Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-02-28 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Ajou University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-07-25 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Jeju National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-02-15 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Chungbuk National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-06-11 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Chosun University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-05-17 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Yeongnam University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2017-07-11 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Gyeongsang National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-03-08 ,
    Recruitment Status by Participating Study Site 15
    Name of Study Pusan National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-07-26 ,
    Recruitment Status by Participating Study Site 16
    Name of Study Inje University Haeundae Paik Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-09-06 ,
    Recruitment Status by Participating Study Site 17
    Name of Study Kosin University Gospel Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-04-21 ,
    Recruitment Status by Participating Study Site 18
    Name of Study Pusan National University Yangsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-09-07 ,
    Recruitment Status by Participating Study Site 19
    Name of Study Gyeongsang National University Changwon Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-09-05 ,
    Recruitment Status by Participating Study Site 20
    Name of Study Keimyung University Daegu Dongsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-06-07 ,
    Recruitment Status by Participating Study Site 21
    Name of Study The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-08-24 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Boston Scientific Korea
    Organization Type Others
    Project ID 지정하고있지 않음

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    The SYNERGY stent (Boston Scientific Corporation, Marlborough, MA), the first BP-DES available in the US, is a novel BP-EES designed to enhance stent healing by incorporating thin (74 μm) platinum chromium (PtCr) struts with an ultrathin (4 μmol/L) bioabsorbable Poly(D, Llactide-co-glycolide) everolimus-eluting (100 μg/cm2) polymer applied only to the abluminal stent surface and which is resorbed within 4 months. The bare metal PtCr platform which remains after polymer resorption may be less pro-inflammatory than gold, cobalt chrome, or cobalt-nickel alloy platforms, and may expedite endothelial cell stent coverage and reduce platelet adhesion compared with PtCr covered by polyvinylidene fluoride DP. The Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De novo Atherosclerotic Lesion (EVOLVE) trial comparing the SYNERGY stent with a DP-PtCr EES on 291 patients found SYNERGY to be non-inferior to the DP-PtCr EES for the angiographic end point of in-stent late lumen loss at 6 months. The EVOLVE II trial randomized 1,684 patients with stable angina or non-ST segment elevation acute coronary syndrome to SYNERGY stent or DP-PtCr EES. SYNERGY was non-inferior to DP-PtCr EES with respect to 1- year TLF (6.7% vs. 6.5%). The rates of clinically indicated TLR or stent thrombosis were not different (2.6 vs. 1.7% and 0.4 vs. 0.6%, respectively), supporting the safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention (PCI).
There is, however, a paucity of data on long-term safety and efficacy of SYNERGY stent in high-risk patients in real-world practice. The present study aims to assess long-term clinical outcome after SYNERGY stent placement in patients with ACS.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 960
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patient inserting Synergy stent for patient with acute coronary syndrome in Korea

    Cohort/Group Description

    1. The informed consent should be signed.
2. Assessment of age, sex, risk factors, clinical diagnosis, angina status, cardiac history, and cardiocerebral event
3. Assessment of cardiocerebral event
4. ECG at follow up visits will only be obtained when clinically indicated such as recurrent chest pain, ischemia, or significant arrhythmias, heart failure or other signs or symptoms of clinical instability
5. Cardiac death, peri-procedural myocardial infarction (CK-MB rise > 10 times of URL), coronary dissection (AHA/ACC type C, D, E), coronary perforation, no reflow (TIMI 0 or 1 during the procedure), stent migration, cardiopulmonary
resuscitation, endotracheal intubation, hemodynamic support (IABP, PCPS), or emergency surgery
6. if baseline lab is done, cardiac markers must be followed every 8-hours for 24 hours post-index procedure. If any elevation was noted after the procedure, additional measurements were performed at 48 hours and 72 hours post-index procedure
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
    • 
						
  • 
							
    
								
    
									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    Patient who undergo percutaneous coronary intervention with SYNERGY stent for acute coronary syndrome
    		
											
    
											
    
												Sampling Method
												
    Non-probablity sampling - We well enroll the patient non-consecutively at about 20 centers in Korea
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												* (I00-I99)Diseases of the circulatory system 
    
												
												
												   (I21.9)Acute myocardial infarction, unspecified 
												
												
												

    
												Patients diagnosed with acute myocardial infarction or unstable angina
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												18Year~No Limit
											    		
										
    
										
    
											
												
    Description
    
												
    -Patients≥18 years of age Patients with ACS
-Patients with lesions requiring interventions amendable for implantation of SYNERGY during the index procedure.
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
    -Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study.
-Patients with hypersensitivity or allergies to one the drug or components indicated in the Instructions for Use of the stent.
-Patients with a life expectancy shorter than 3 years
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											/Safety/Efficacy
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    major adverse cardiac events defined  as a composite of all-cause death, MI and TVR by PCI or CABG
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    major bleeding (BARC  types 2, 3, or 5 bleeding)
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
											
    
												
													Secondary Outcome(s) 2
												
											
    
											
    
												Outcome
												
    ischemia-driven TVR
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
											
    
												
													Secondary Outcome(s) 3
												
											
    
											
    
												Outcome
												
    all-cause death
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
											
    
												
													Secondary Outcome(s) 4
												
											
    
											
    
												Outcome
												
    myocardial infarction
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
											
    
												
													Secondary Outcome(s) 5
												
											
    
											
    
												Outcome
												
    TVR by PCI or CABG
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
											
    
												
													Secondary Outcome(s) 6
												
											
    
											
    
												Outcome
												
    stent thrombosis
    		
											
    
											
    
												Timepoint
												
    at 3 years
    		
											
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													No
												
												
												
											
										
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													
													No
													
												
											
										
    
										
									    
								
    
							
    
						
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