Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )

Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.

Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.

• Study Type: Observational
• Enrollment (Actual): 3001

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 38 Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Coronary artery disease requiring drug eluting stents

Description

Inclusion Criteria:

• Patients receiving Promus Element 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 with cardiogenic shock

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Promus Element stent; Patients receiving Promus Element stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	12 months post stenting procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death (all-cause and cardiac)		30 days
Myocardial infarction		30 days
Composite of death or MI		30 days
Composite of cardiac death or MI		30 days
Target Vessel Revascularization		30 days
Target lesion revascularization		30 days
Stent thrombosis		30 days
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, participants will be followed for the duration of hospital stay, an expected average of 3 days.	3 days in average
Death (all cause and cardiac)		6 months
Death (all cause and cardiac)		yearly up to 5 years
Myocardial infarction		6 months
Myocardial infarction		yearly up to 5 years
Composite of death or MI		6 months
Composite of death or MI		yearly up to 5 years
Composite of cardiac death or MI		6 months
Composite of cardiac death or MI		yearly up to 5 years
Target Vessel Revascularization		6 months
Target Vessel Revascularization		yearly up to 5 years
Target lesion revascularization		6 months
Target lesion revascularization		yearly up to 5 years
Stent thrombosis		6 months
Stent thrombosis		yearly up to 5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Boston Scientific Corporation; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 22, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CVRF2010-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No