Clinical trial NCT01350791: Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )
Official title: Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Boston Scientific Corporation
First posted: 2011-05-10
Enrollment: 3001
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary artery disease requiring drug eluting stents

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: 12 months post stenting procedure
Secondary outcomes:
measure: Death (all-cause and cardiac)
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
measure: Composite of death or MI
timeFrame: 30 days
measure: Composite of cardiac death or MI
timeFrame: 30 days
measure: Target Vessel Revascularization
timeFrame: 30 days
measure: Target lesion revascularization
timeFrame: 30 days
measure: Stent thrombosis
timeFrame: 30 days
measure: 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)
timeFrame: 3 days in average
measure: Death (all cause and cardiac)
timeFrame: 6 months
measure: Death (all cause and cardiac)
timeFrame: yearly up to 5 years
measure: Myocardial infarction
timeFrame: 6 months
measure: Myocardial infarction
timeFrame: yearly up to 5 years
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: yearly up to 5 years
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: yearly up to 5 years
measure: Target Vessel Revascularization
timeFrame: 6 months
measure: Target Vessel Revascularization
timeFrame: yearly up to 5 years
measure: Target lesion revascularization
timeFrame: 6 months
measure: Target lesion revascularization
timeFrame: yearly up to 5 years
measure: Stent thrombosis
timeFrame: 6 months
measure: Stent thrombosis
timeFrame: yearly up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 38 Centers
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, Catholic University of Korea
name: Ki Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: