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

June 19, 2018 updated by: Seung-Jung Park

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
XIENCE PRIME stents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Time Frame: 12 months post procedure
12 months post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Death (all cause and cardiac)
Time Frame: 6 months
6 months
Death (all cause and cardiac)
Time Frame: yearly up to 5 years
yearly up to 5 years
Composite of death or MI
Time Frame: 6 months
6 months
Composite of death or MI
Time Frame: yearly up to 5 years
yearly up to 5 years
Composite of cardiac death or MI
Time Frame: 6 months
6 months
Composite of cardiac death or MI
Time Frame: yearly up to 5 years
yearly up to 5 years
Composite of death or MI
Time Frame: one month
one month
Composite of cardiac death or MI
Time Frame: one month
one month
MI
Time Frame: one month
one month
MI
Time Frame: 6 months
6 months
TVR
Time Frame: one month
one month
TVR
Time Frame: 6 months
6 months
Target-lesion revascularization (TLR)
Time Frame: one month
one month
Target-lesion revascularization (TLR)
Time Frame: 6 months
6 months
Stent thrombosis (ARC criteria)
Time Frame: one month
one month
Stent thrombosis (ARC criteria)
Time Frame: 6 months
6 months
Death (all cause and cardiac)
Time Frame: one month
one month
MI
Time Frame: yearly up to 5 years
yearly up to 5 years
TVR
Time Frame: yearly up to 5 years
yearly up to 5 years
Target-lesion revascularization (TLR)
Time Frame: yearly up to 5 years
yearly up to 5 years
Stent thrombosis (ARC criteria)
Time Frame: yearly up to 5 years
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
At discharge from the index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott
CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVRF2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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