Clinical trial NCT06177743: IRIS-Coroflex NEO Cohort
Official title: Evaluation of Effectiveness and Safety of Coroflex ISAR NEO Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Stenosis
Coronary Artery Disease
Keywords: percutaneous coronary intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: The CardioVascular Research Foundation (CVRF)
First posted: 2023-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Coroflex ISAR NEO stents.

Brief summary: 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: Inclusion Criteria:

1. Patients ≥ 19 years old
2. Patients receiving Coroflex ISAR NEO stents.
3. 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.

Exclusion Criteria:

1. Patients with a mixture of other DESs
2. Terminal illness with life expectancy \<1 year.
3. Patients with cardiogenic shock

Primary outcomes:
measure: the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 12 months
Secondary outcomes:
measure: the event rate of all cause death
timeFrame: 5 years
measure: the event rate of cardiac death
timeFrame: 5 years
measure: the event rate of myocardial infarction
timeFrame: 5 years
measure: the composite event rate of death, or myocardial infarction (MI)
timeFrame: 5 years
measure: the composite event rate of cardiac death, or myocardial infarction (MI)
timeFrame: 5 years
measure: the event rate of Target- Vessel Revascularization (TVR)
timeFrame: 5 years
measure: the event rate of Target- lesion Revascularization (TLR)
timeFrame: 5 years
measure: the event rate of stent thrombosis
timeFrame: 5 years
measure: the event rate of stroke
timeFrame: 5 years
measure: the event rate of Procedural success
timeFrame: 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic Univ. of Korea BUCHEON ST.Mary's hospital
city: Daegu
country: Korea, Republic of
facility: Veterans Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Ilsan
country: Korea, Republic of
facility: Myongji Hospital
city: Sejong
country: Korea, Republic of
facility: Sejong Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: The Catholic university of Korea, ST. Vincent's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center
Study officials:
References: