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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01350791

Enrollment

3001

Registered

2011-05-10

Start date

2010-05-31

Completion date

2016-12-31

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Myocardial infarction	30 days	—
Composite of death or MI	30 days	—
Composite of cardiac death or MI	30 days	—
Target Vessel Revascularization	30 days	—
Death (all-cause and cardiac)	30 days	—
Stent thrombosis	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)	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.
Death (all cause and cardiac)	6 months	—
Target lesion revascularization	30 days	—

Countries

South Korea

Outcome results