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

Seung-Jung Park

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01350791

CVRF2010-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,001 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,001 participants in 1 patient group

Promus Element stent

Description:

Patients receiving Promus Element stents