ION US Post-Approval Study
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 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|
- 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%.
- 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.
|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)|
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.
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.
Show 40 Study Locations
|Principal Investigator:||Louis A Cannon, MD||Northern Michigan Hospital|
|Principal Investigator:||Carey D Kimmelstiel, MD||Tufts Medical Center|