Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date May 2010
End date October 2013
Trial size 3018 participants
Trial identifier NCT01350791, CVRF2010-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients receiving Promus Element stents

Primary Outcomes

Measure
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
time frame: 12 months post stenting procedure

Secondary Outcomes

Measure
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)
time frame: 3 days in average
Death (all cause and cardiac)
time frame: 6 months
Death (all cause and cardiac)
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
Principal investigator Seung-Jung Park, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.