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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348399
First Posted: May 5, 2011
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CardioVascular Research Foundation, Korea
Abbott
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
  Purpose
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)

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) [ Time Frame: 12 months post procedure ]

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

Enrollment: 2000
Actual Study Start Date: April 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
XIENCE PRIME stents

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving XIENCE PRIME stents.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348399


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Soonchunhyang Univ. Bucheon Hospital
Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
Cheonan, Korea, Republic of
Gangwon National Univ. Hospital
Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Ilsan, Korea, Republic of
Presbyterian Medical Center
Jeonju, Korea, Republic of
Gyeongsang National University Hospital
Jinju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Bundang Cha Medical Center
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyunghee University Hospital at Gangdong
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
St.carollo Hospital
Suncheon, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
Suwon, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Abbott
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
Principal Investigator: Ki Bae Seung, MD, PhD Seoul St. Mary's Hospital, Catholic University of Korea
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01348399     History of Changes
Other Study ID Numbers: CVRF2011-01
First Submitted: May 4, 2011
First Posted: May 5, 2011
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Coronary artery disease requiring drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases