The IRIS-Resolute Integrity (IRIS-Integrity)

Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01392846

Enrollment

3000

Registered

2011-07-13

Start date

2011-07-31

Completion date

2020-03-02

Last updated

2021-09-13

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

This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.

Detailed description

Consecutive Percutaneous Coronary Intervention patients receiving Resolute Integrity stent will be compared with other concurrent Drug Eluting Stents.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with significant coronary artery disease and receiving Resolute Integrity stent. * 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	Description
Death (all cause and cardiac)	one month	—
Myocardial Infarction	one month	—
Composite of death or MI	one month	—
Composite of cardiac death or MI	one month	—
Stroke	12 months and yearly up to 5 years	—
Target-lesion revascularization	one month	—
Stent thrombosis	one month	—
Procedural success	at day 1	It is 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.
Target Vessel Revascularization	one month	—

Countries

South Korea

Outcome results