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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014