ION US Post-Approval Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | February 2015 |
A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
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.
Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
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.
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.
Inclusion Criteria:
Consented subjects receiving one or more ION(TM)Coronary Stents
Exclusion Criteria:
Subjects not clinically indicated to receive an ION (TM)Coronary Stent
We found this trial at
40
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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