ION US Post-Approval Study
A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
1 other identifier
observational
1,120
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Typical duration for all trials
40 active sites
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
First Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 25, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 20, 2015
CompletedFebruary 4, 2016
January 1, 2016
1.8 years
August 22, 2011
April 23, 2014
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac Death or Myocardial Infarction (CD/MI)
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 Outcomes (1)
Stent Thrombosis
Annually, after the first year, through 2 years.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Consented subjects receiving one or more ION(TM)Coronary Stents
You may not qualify if:
- Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401, United States
Bakersfield Memorial Hospital
Bakersfield, California, 93301, United States
Alvarado Hospital
San Diego, California, 92121, United States
Northside Hospital and Heart Institute
St. Petersburg, Florida, 33709, United States
University Community Hospital
Tampa, Florida, 33613, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
King's Daughters Medical Center - Kentucky Heart Inst
Ashland, Kentucky, 41101, United States
Maine Medical Center
Portland, Maine, 04102, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Sparrow Health System - Sparrow Hospital
Lansing, Michigan, 48910, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, 49085, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501, United States
Freeman West Hospital
Joplin, Missouri, 64804, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 08035, United States
Jersey Shore University Medical Center
Sea Girt, New Jersey, 08750, United States
St. Joseph's Hospital Health Center
Liverpool, New York, 13088, United States
St. Elizabeth Medical Center
Utica, New York, 13501, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
St. Mary Medical Center
Yardley, Pennsylvania, 19067, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572, United States
Regional Hospital
Jackson, Tennessee, 38305, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226, United States
CRSTI/Medical City Dallas
Dallas, Texas, 75230, United States
Kingwood Medical Center Hospital
Kingwood, Texas, 77339, United States
Methodist Texsan Hospital
San Antonio, Texas, 78201, United States
Meriter Hospital, Inc.
Madison, Wisconsin, 53713, United States
CaRE Foundation, Inc.
Wausau, Wisconsin, 54401, United States
Related Publications (2)
Cannon L, Kimmelstiel CD, Kellett M, White A, Hill R, Grady T, Myers PR, Underwood P, Dawkins KD. One-year real-world outcomes following implantation of the ION paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Primary endpoint results of the ION U.S. post-approval registry [abstract]. J Am Coll Cardiol. 2013; 62 (18 SUPPL. 1): B58
RESULTKimmelstiel CD, Cannon LA, Jobe RL, Stoler R, Pow T, Ganim R, Kayser R, Allocco DJ, Dawkins KD. Two-Year "Real-World" Outcomes Following Implantation of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent in Routine Clinical Practice: Results From the ION U.S. Post-Approval Registry. Presented at: The Transcatheter and Cardiovascular Therapeutics Annual Meeting 2014; Washington, D.C, USA. September 13 - 17, 2014.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Maurer, MPH; Director, Clinical Trials
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Louis A Cannon, MD
Northern Michigan Hospital
- PRINCIPAL INVESTIGATOR
Carey D Kimmelstiel, MD
Tufts Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 25, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2013
Study Completion
February 1, 2015
Last Updated
February 4, 2016
Results First Posted
March 20, 2015
Record last verified: 2016-01