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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350791
• Other study ID #: CVRF2010-04
• Status: Completed
• Phase: N/A
• First received: April 22, 2011
• Last updated: July 19, 2017
• Start date: May 2010
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3001
• Est. completion date: December 2016
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	38 Centers	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Boston Scientific Corporation, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)		12 months post stenting procedure
Secondary	Death (all-cause and cardiac)		30 days
Secondary	Myocardial infarction		30 days
Secondary	Composite of death or MI		30 days
Secondary	Composite of cardiac death or MI		30 days
Secondary	Target Vessel Revascularization		30 days
Secondary	Target lesion revascularization		30 days
Secondary	Stent thrombosis		30 days
Secondary	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
Secondary	Death (all cause and cardiac)		6 months
Secondary	Death (all cause and cardiac)		yearly up to 5 years
Secondary	Myocardial infarction		6 months
Secondary	Myocardial infarction		yearly up to 5 years
Secondary	Composite of death or MI		6 months
Secondary	Composite of death or MI		yearly up to 5 years
Secondary	Composite of cardiac death or MI		6 months
Secondary	Composite of cardiac death or MI		yearly up to 5 years
Secondary	Target Vessel Revascularization		6 months
Secondary	Target Vessel Revascularization		yearly up to 5 years
Secondary	Target lesion revascularization		6 months
Secondary	Target lesion revascularization		yearly up to 5 years
Secondary	Stent thrombosis		6 months
Secondary	Stent thrombosis		yearly up to 5 years