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
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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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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