NCT01350791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3.4 years

First QC Date

April 22, 2011

Last Update Submit

July 19, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    12 months post stenting procedure

Secondary Outcomes (22)

  • Death (all-cause and cardiac)

    30 days

  • Myocardial infarction

    30 days

  • Composite of death or MI

    30 days

  • Composite of cardiac death or MI

    30 days

  • Target Vessel Revascularization

    30 days

  • +17 more secondary outcomes

Study Arms (1)

Promus Element stent

Patients receiving Promus Element stents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Coronary artery disease requiring drug eluting stents

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy \<1 year
  • Patients with cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

38 Centers

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Seung-Jung Park, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Ki Bae Seung, MD, PhD

    Seoul St. Mary's Hospital, Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

April 22, 2011

First Posted

May 10, 2011

Study Start

May 1, 2010

Primary Completion

October 1, 2013

Study Completion

December 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

KR(1)