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Active, Not Recruiting

NCT Number: NCT02720419

IRIS-Synergy Cohort in the IRIS-DES Registry

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composite event

    Time frame: 1 year

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

Secondary outcomes

  1. All death

    Time frame: 5 years

  2. Cardiac death

    Time frame: 5 years

  3. Myocardial infarction

    Time frame: 5 years

  4. Composite event of death or myocardial infarction

    Time frame: 5 years

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5 years

  6. Target vessel revascularization

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 5 years

  10. Procedural success

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jung-min Ahn

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS Synergy

Important dates

Study start
2016
Primary completion
2023
Study completion
2027
First posted
Mar 25, 2016
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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