Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | May 2007 |
| End Date: | January 2014 |
The purposes of this study are:
1. To provide additional safety and effectiveness information on the commercial use of
Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection
Device.
2. To evaluate rare and unanticipated adverse events.
3. To evaluate the physician level of experience with carotid artery stenting procedures
with adverse event rates.
1. To provide additional safety and effectiveness information on the commercial use of
Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection
Device.
2. To evaluate rare and unanticipated adverse events.
3. To evaluate the physician level of experience with carotid artery stenting procedures
with adverse event rates.
Inclusion Criteria:
- 18 years and above
- Informed consent
- Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery
disease per Instructions for Use
- Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined
anatomical or clinical high risk criteria
Exclusion Criteria:
- Subjects with contraindications as outlined in the Instructions for Use
We found this trial at
2
sites
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