ION US Post-Approval Study

Sponsored by Boston Scientific Corporation

Purpose

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.

 

Condition	Intervention
Atherosclerosis Coronary Artery Disease	Devoce: ION™ Coronary Stent System

Arms	Assigned Interventions
ION Registry: Experimental The ION Registry population will contain the first 1115 consecutive, consenting patients Intervention: Device: ION™ Coronary Stent System	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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria
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

Contacts and Locations

Physicians
Ameer Kabour, MD
Tarif Kanaan, MD

Coordinators:
Michelle Hickam, BSN, CCRC
Julie Neidhardt, BSN, CCRC
Brenda Hoagland, RN, CCRC

Please contact us at 419-251-4919 for further information regarding this study. ,/b>