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IRIS-Coroflex NEO Cohort

ConditionsCoronary Artery StenosisCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeung-Jung Park

About this trial

The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 19 years old

Patients receiving Coroflex ISAR NEO stents.

The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Disqualifiers

Patients with a mixture of other DESs

Terminal illness with life expectancy <1 year.

Patients with cardiogenic shock

Trial population

Patients receiving Coroflex ISAR NEO stents.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Coroflex ISAR NEO stent

    Device

    Percutaneous coronary intervention with Coroflex ISAR NEO stent

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Coroflex ISAR NEO1 intervention

Trial outcomes

Primary outcomes

1

the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Time frame
12 months

Secondary outcomes

1

the event rate of all cause death

Time frame
5 years
2

the event rate of cardiac death

Time frame
5 years
3

the event rate of myocardial infarction

Time frame
5 years
4

the composite event rate of death, or myocardial infarction (MI)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seung-Jung Park

Lead sponsor

Asan Medical Center

Sponsor institution

The CardioVascular Research Foundation (CVRF)

Collaborator

Source ClinicalTrials.gov
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