IRIS-Synergy Cohort in the IRIS-DES Registry (IRIS Synergy)

Evaluation of Effectiveness and Safety of Synergy™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Busan, Korea, Republic of
    • Haeundae paik hospital, inje university
  • Busan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Chuncheon, Korea, Republic of
    • Hallym University Chuncheon Sacred Heart Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Incheon St. Mary's Hospital, The Catholic University of Korea
  • Jeju, Korea, Republic of
    • Cheju Halla General Hopsital
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • Seongnam, Korea, Republic of
    • CHA Bundang Medical Center, CHA University
  • Seongnam, Korea, Republic of
    • Seoul university Bundang hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, St. Paul's hospital
  • Seoul, Korea, Republic of
    • Kyung-Hee University Hospital
  • Wonju, Korea, Republic of
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Synergy stent

Description

Inclusion Criteria:

• Age 19 and more
• Intervention with Synergy stent
• Agreed with written informed consent form

Exclusion Criteria:

• Intervention with Synergy stent and other drug eluting stent at the same time
• Life expectancy of 1year and under
• Cardiac shock

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Synergy stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event	The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		5 years
Composite event of death or myocardial infarction		5 years
Composite event of cardiac death or myocardial infarction		5 years
Stent thrombosis	DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;	5 years
Stroke		5 years
Procedural success	Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death	3 days
All death		5 years
Myocardial infarction		5 years
Target vessel revascularization	Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %	5 years
Target lesion revascularization	Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.	5 years

Collaborators and Investigators

• Sponsor: Jung-min Ahn
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): February 24, 2023
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; drug eluting stent; real world
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2016-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.