Overview

This trial is active, not recruiting.

Conditions atherosclerosis, coronary artery disease
Treatment ion™ coronary stent system
Sponsor Boston Scientific Corporation
Start date September 2011
End date May 2013
Trial size 1115 participants
Trial identifier NCT01422889, S2065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The ION Registry population will contain the first 1115 consecutive, consenting patients
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.

Primary Outcomes

Measure
Rate of cardiac death or myocardial infarction (MI)
time frame: 12 Months

Secondary Outcomes

Measure
Stent thrombosis (ST) rate
time frame: Annually, after the first year, through 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Principal investigator Louis A Cannon, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.