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.
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
3,001
38 Centers
Seoul, South Korea
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time frame: 12 months post stenting procedure
Death (all-cause and cardiac)
Time frame: 30 days
Myocardial infarction
Time frame: 30 days
Composite of death or MI
Time frame: 30 days
Composite of cardiac death or MI
Time frame: 30 days
Target Vessel Revascularization
Time frame: 30 days
Target lesion revascularization
Time frame: 30 days
Stent thrombosis
Time frame: 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.
Time frame: 3 days in average
Death (all cause and cardiac)
Time frame: 6 months
Death (all cause and cardiac)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: yearly up to 5 years
Myocardial infarction
Time frame: 6 months
Myocardial infarction
Time frame: yearly up to 5 years
Composite of death or MI
Time frame: 6 months
Composite of death or MI
Time frame: yearly up to 5 years
Composite of cardiac death or MI
Time frame: 6 months
Composite of cardiac death or MI
Time frame: yearly up to 5 years
Target Vessel Revascularization
Time frame: 6 months
Target Vessel Revascularization
Time frame: yearly up to 5 years
Target lesion revascularization
Time frame: 6 months
Target lesion revascularization
Time frame: yearly up to 5 years
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: yearly up to 5 years