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IRIS Synergy: IRIS-Synergy Cohort in the IRIS-DES Registry

Sponsor
Jung-min Ahn (Other)
Overall Status
Recruiting
CT.gov ID
NCT02720419
Collaborator
CardioVascular Research Foundation, Korea (Other)
3,000
Enrollment
29
Locations
124
Anticipated Duration (Months)
103.4
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Effectiveness and Safety of Synergy™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
    Actual Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Synergy stent

    Outcome Measures

    Primary Outcome Measures

    1. Composite event [1 year]

      The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

    Secondary Outcome Measures

    1. All death [5 years]

    2. Cardiac death [5 years]

    3. Myocardial infarction [5 years]

    4. Composite event of death or myocardial infarction [5 years]

    5. Composite event of cardiac death or myocardial infarction [5 years]

    6. Target vessel revascularization [5 years]

      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 %

    7. Target lesion revascularization [5 years]

      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.

    8. Stent thrombosis [5 years]

      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;

    9. Stroke [5 years]

    10. Procedural success [3 days]

      Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Chun Hyang University Hospital Bucheon Bucheon Korea, Republic of
    2 Haeundae paik hospital, inje university Busan Korea, Republic of
    3 Inje university Pusan Paik hospital Busan Korea, Republic of
    4 Kosin University Gospel Hospital Busan Korea, Republic of
    5 Pusan National University Hospital Busan Korea, Republic of
    6 Pusan National University Yangsan Hospital Busan Korea, Republic of
    7 Soon Chun Hyang University Hospital Cheonan Korea, Republic of
    8 Gangwon National Univ. Hospital Chuncheon Korea, Republic of
    9 Hallym University Chuncheon Sacred Heart Hospital Chuncheon Korea, Republic of
    10 Daegu Catholic University Medical Center Daegu Korea, Republic of
    11 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
    12 Yeungnam University Medical Center Daegu Korea, Republic of
    13 Chungnam National University Hospital Daejeon Korea, Republic of
    14 The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon Korea, Republic of
    15 Gangneung Asan Hospital Gangneung Korea, Republic of
    16 Chonnam National University Hospital Gwangju Korea, Republic of
    17 Gachon University Gil Hospital Incheon Korea, Republic of
    18 Incheon St. Mary's Hospital, The Catholic University of Korea Incheon Korea, Republic of
    19 Cheju Halla General Hopsital Jeju Korea, Republic of
    20 Kwangju Christian Hospital Kwangju Korea, Republic of
    21 CHA Bundang Medical Center, CHA University Seongnam Korea, Republic of
    22 Seoul university Bundang hospital Seongnam Korea, Republic of
    23 Asan Medical Center Seoul Korea, Republic of
    24 Eulji general hospital Seoul Korea, Republic of
    25 Korea University Guro Hospital Seoul Korea, Republic of
    26 Kyung-Hee University Hospital Seoul Korea, Republic of
    27 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of
    28 The Catholic University of Korea, St. Paul's hospital Seoul Korea, Republic of
    29 Wonju Severance Christian Hospital Wonju Korea, Republic of

    Sponsors and Collaborators

    • Jung-min Ahn
    • CardioVascular Research Foundation, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-min Ahn, assistant professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02720419
    Other Study ID Numbers:
    • AMCCV2016-03
    First Posted:
    Mar 25, 2016
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jung-min Ahn, assistant professor, Asan Medical Center
    drug eluting stent
    percutaneous coronary intervention
    real world
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Sep 13, 2021