ION US Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01422889
First received: August 22, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.


Condition Intervention
Atherosclerosis
Coronary Artery Disease
Device: ION™ Coronary Stent System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Rate of cardiac death or myocardial infarction (MI) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    The rate of cardiac death or myocardial infarction (MI) expressed as the proportion of ION PERSEUS-like subjects who experience cardiac death or MI among all PERSEUS-like subjects who either experience 12-month Cardiac Death or MI or survive free of Cardiac Death or MI for at least 335 days (Day 365 minus 30 days). Statistical testing will be performed to determine if the Cardiac Death or MI rate for the ION™ stent is non-inferior to the Cardiac Death or MI rate for the TAXUS Liberté stent, assuming a non-inferiority margin of 1.2%.


Secondary Outcome Measures:
  • Stent thrombosis (ST) rate [ Time Frame: Annually, after the first year, through 5 years ] [ Designated as safety issue: Yes ]
    Using Academic Research Consortium (ARC) definition, the stent thrombosis (ST) rate in the PERSEUS-like ION™ population will be analyzed. Statistical testing will be used to determine if the ION stent meets the performance goal of 1.0% (expected rate of 0.4% + delta of 0.6%) in terms of annual increase in ST rate in PERSUS-like ION population.


Estimated Enrollment: 1115
Study Start Date: September 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ION Registry
The ION Registry population will contain the first 1115 consecutive, consenting patients
Device: ION™ Coronary Stent System
This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.

Detailed Description:

The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Consecutive subjects receiving one or more ION(TM)Coronary Stents

Exclusion Criteria:

Subjects not clinically indicated to receive an ION (TM)Coronary Stent

  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: NCT01422889

  Show 40 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Louis A Cannon, MD Northern Michigan Hospital
Principal Investigator: Carey D Kimmelstiel, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01422889     History of Changes
Other Study ID Numbers: S2065
Study First Received: August 22, 2011
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Atherosclerosis
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on September 16, 2014