NCT01350791

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,001 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-10-01
• Completion: 2016-12-01
• First posted: 2011-05-10
• Last updated: 2017-07-21

Locations

1 site across 1 country: South Korea