Clinical trial NCT01348399: Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)
Official title: Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease requiring drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Abbott
First posted: 2011-05-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving XIENCE PRIME stents.

Brief summary: The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)

Detailed description: This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* Patients receiving XIENCE PRIME 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.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients presented with cardiogenic shock

Primary outcomes:
measure: composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Death (all cause and cardiac)
timeFrame: one month
measure: Death (all cause and cardiac)
timeFrame: 6 months
measure: Death (all cause and cardiac)
timeFrame: yearly up to 5 years
measure: MI
timeFrame: one month
measure: MI
timeFrame: 6 months
measure: MI
timeFrame: yearly up to 5 years
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: yearly up to 5 years
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: yearly up to 5 years
measure: TVR
timeFrame: one month
measure: TVR
timeFrame: 6 months
measure: TVR
timeFrame: yearly up to 5 years
measure: Target-lesion revascularization (TLR)
timeFrame: one month
measure: Target-lesion revascularization (TLR)
timeFrame: 6 months
measure: Target-lesion revascularization (TLR)
timeFrame: yearly up to 5 years
measure: Stent thrombosis (ARC criteria)
timeFrame: one month
measure: Stent thrombosis (ARC criteria)
timeFrame: 6 months
measure: Stent thrombosis (ARC criteria)
timeFrame: yearly up to 5 years
measure: Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)
timeFrame: At discharge from the index hospitalization
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang Univ. Bucheon Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang Cha Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, Catholic University of Korea
name: Ki Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: