N/A
Completed N=1,500
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Source: ClinicalTrials.gov NCT00530504 ↗Enrolled (actual)
1,500
Serious AEs
36.9%
Results posted
Sep 2015
Primary outcomePrimary: Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. — 99 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. |
99 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00530504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.