Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01350791
- Lead Sponsor
- Seung-Jung Park
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3001
- 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.
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients with cardiogenic shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) 12 months post stenting procedure
- Secondary Outcome Measures
Name Time Method Death (all-cause and cardiac) 30 days Target Vessel Revascularization yearly up to 5 years Composite of cardiac death or MI yearly up to 5 years Stent thrombosis yearly up to 5 years Death (all cause and cardiac) yearly up to 5 years Composite of death or MI yearly up to 5 years Target lesion revascularization yearly up to 5 years 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) 3 days in average At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
Myocardial infarction yearly up to 5 years
Trial Locations
- Locations (1)
38 Centers
🇰🇷Seoul, Korea, Republic of