ION US Post-Approval Study

January 6, 2016 updated by: Boston Scientific Corporation

A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Medical Center
    • California
      • Bakersfield, California, United States, 93301
        • Bakersfield Memorial Hospital
      • San Diego, California, United States, 92121
        • Alvarado Hospital
    • Florida
      • St. Petersburg, Florida, United States, 33709
        • Northside Hospital and Heart Institute
      • Tampa, Florida, United States, 33613
        • University Community Hospital
    • Georgia
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Krannert Institute of Cardiology
      • Indianapolis, Indiana, United States, 46250
        • Indiana Heart Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center - Kentucky Heart Inst
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Sparrow Health System - Sparrow Hospital
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
      • St. Joseph, Michigan, United States, 49085
        • Lakeland Hospitals at St. Joseph
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Memorial Hospital at Gulfport
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Freeman West Hospital
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Our Lady of Lourdes Medical Center
      • Sea Girt, New Jersey, United States, 08750
        • Jersey Shore University Medical Center
    • New York
      • Liverpool, New York, United States, 13088
        • St. Joseph's Hospital Health Center
      • Utica, New York, United States, 13501
        • St. Elizabeth Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Toledo, Ohio, United States, 43608
        • Mercy St. Vincent Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Yardley, Pennsylvania, United States, 19067
        • St. Mary Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Sisters of Charity Providence Hospital
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Regional Medical Center
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Regional Hospital
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart & Vascular Hospital
      • Dallas, Texas, United States, 75230
        • CRSTI/Medical City Dallas
      • Kingwood, Texas, United States, 77339
        • Kingwood Medical Center Hospital
      • San Antonio, Texas, United States, 78201
        • Methodist Texsan Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Meriter Hospital, Inc.
      • Wausau, Wisconsin, United States, 54401
        • CaRE Foundation, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consented subjects admitted to the cardiac catheterization laboratory for percutaneous transluminal coronary angioplasty and who are eligible to receive an ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ION Registry
The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Death or Myocardial Infarction (CD/MI)
Time Frame: 12 Months
Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent Thrombosis
Time Frame: Annually, after the first year, through 2 years.
Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Annually, after the first year, through 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Louis A Cannon, MD, Northern Michigan Hospital
  • Principal Investigator: Carey D Kimmelstiel, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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