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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01348399

Enrollment

2000

Registered

2011-05-05

Start date

2011-04-30

Completion date

2017-09-30

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease requiring drug eluting 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
MI	one month
Composite of death or MI	one month
Composite of cardiac death or MI	one month
Death (all cause and cardiac)	one month
Target-lesion revascularization (TLR)	one month
Stent thrombosis (ARC criteria)	one month
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
TVR	one month

Countries

South Korea

Outcome results