ION US Post-Approval Study
- Conditions
- AtherosclerosisCoronary Artery Disease
- Interventions
- Device: ION™ Coronary Stent System
- Registration Number
- NCT01422889
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1120
Consented subjects receiving one or more ION(TM)Coronary Stents
Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ION Registry ION™ Coronary Stent System 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.
- Primary Outcome Measures
Name Time Method Cardiac Death or Myocardial Infarction (CD/MI) 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.
- Secondary Outcome Measures
Name Time Method Stent Thrombosis 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.
Trial Locations
- Locations (40)
Our Lady of Lourdes Medical Center
🇺🇸Haddon Heights, New Jersey, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
NEA Baptist Memorial Hospital
🇺🇸Jonesboro, Arkansas, United States
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
Bakersfield Memorial Hospital
🇺🇸Bakersfield, California, United States
Northside Hospital and Heart Institute
🇺🇸St. Petersburg, Florida, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
Kootenai Medical Center
🇺🇸Coeur d'Alene, Idaho, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
King's Daughters Medical Center - Kentucky Heart Inst
🇺🇸Ashland, Kentucky, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Sparrow Health System - Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Lakeland Hospitals at St. Joseph
🇺🇸St. Joseph, Michigan, United States
Memorial Hospital at Gulfport
🇺🇸Gulfport, Mississippi, United States
Freeman West Hospital
🇺🇸Joplin, Missouri, United States
St. Elizabeth Medical Center
🇺🇸Utica, New York, United States
Jersey Shore University Medical Center
🇺🇸Sea Girt, New Jersey, United States
St. Joseph's Hospital Health Center
🇺🇸Liverpool, New York, United States
Wake Medical Center
🇺🇸Raleigh, North Carolina, United States
Mercy St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
St. Mary Medical Center
🇺🇸Yardley, Pennsylvania, United States
Sisters of Charity Providence Hospital
🇺🇸Columbia, South Carolina, United States
Grand Strand Regional Medical Center
🇺🇸Myrtle Beach, South Carolina, United States
Regional Hospital
🇺🇸Jackson, Tennessee, United States
CRSTI/Medical City Dallas
🇺🇸Dallas, Texas, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
Kingwood Medical Center Hospital
🇺🇸Kingwood, Texas, United States
CaRE Foundation, Inc.
🇺🇸Wausau, Wisconsin, United States
Alvarado Hospital
🇺🇸San Diego, California, United States
University Community Hospital
🇺🇸Tampa, Florida, United States
Krannert Institute of Cardiology
🇺🇸Indianapolis, Indiana, United States
Indiana Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Methodist Texsan Hospital
🇺🇸San Antonio, Texas, United States
Meriter Hospital, Inc.
🇺🇸Madison, Wisconsin, United States