Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Duk-Woo Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01350791
First received: April 22, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of PROMUS Element™ in Routine Clinical Practice; A Multicenter, PROSPECTIVE OBSERVATIONAL STUDY

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: 12 months post stenting procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all-cause and cardiac) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 3018
Study Start Date: May 2010
Estimated Study Completion Date: April 2016
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Promus Element stent
Patients receiving Promus Element stents

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coronary artery disease requiring drug eluting stents

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350791

Locations
Korea, Republic of
41 Centers
Seoul, Korea, Republic of
Sponsors and Collaborators
Duk-Woo Park
Boston Scientific Corporation
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
Principal Investigator: Ki Bae Seung, MD, PhD Seoul St. Mary's Hospital, Catholic University of Korea
  More Information

No publications provided

Responsible Party: Duk-Woo Park, MD,PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01350791     History of Changes
Other Study ID Numbers: CVRF2010-04
Study First Received: April 22, 2011
Last Updated: August 6, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014