Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)

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

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)

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Soonchunhyang Univ. Bucheon Hospital
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Jeonju, Korea, Republic of
    • Presbyterian Medical Center
  • Jinju, Korea, Republic of
    • Gyeongsang National University Hospital
  • Kwangju, Korea, Republic of
    • Kwangju Christian hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Seongnam, Korea, Republic of
    • Bundang CHA Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Kyunghee University Hospital at Gangdong
  • Seoul, Korea, Republic of
    • KangNam Sacred Heart Hospital
  • Suncheon, Korea, Republic of
    • St.carollo Hospital
  • Suwon, Korea, Republic of
    • The Catholic University of Korea St. Vincent's Hospital
  • Uijeongbu, Korea, Republic of
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving XIENCE PRIME stents.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
XIENCE PRIME stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Death (all cause and cardiac)	6 months
Death (all cause and cardiac)	yearly up to 5 years
Composite of death or MI	6 months
Composite of death or MI	yearly up to 5 years
Composite of cardiac death or MI	6 months
Composite of cardiac death or MI	yearly up to 5 years
Composite of death or MI	one month
Composite of cardiac death or MI	one month
MI	one month
MI	6 months
TVR	one month
TVR	6 months
Target-lesion revascularization (TLR)	one month
Target-lesion revascularization (TLR)	6 months
Stent thrombosis (ARC criteria)	one month
Stent thrombosis (ARC criteria)	6 months
Death (all cause and cardiac)	one month
MI	yearly up to 5 years
TVR	yearly up to 5 years
Target-lesion revascularization (TLR)	yearly up to 5 years
Stent thrombosis (ARC criteria)	yearly up to 5 years
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)	At discharge from the index hospitalization

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Abbott; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery disease requiring drug eluting stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CVRF2011-01