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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Abbott
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01348399
First received: May 4, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all cause and cardiac) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: one month ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • TVR [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization (TLR) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2013 (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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348399

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
29 Centers Recruiting
Seoul, 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

No publications provided

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
Study First Received: May 4, 2011
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013