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ION US Post-Approval Study Banner

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.

 

ConditionIntervention
Atherosclerosis
Coronary Artery Disease
Devoce: ION™ Coronary Stent System


ArmsAssigned 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.

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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

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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>
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