N/A
N=1,500
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Carotid Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00530504 ↗Enrolled (actual)
1,500
Serious AEs
36.9%
Results posted
Sep 2015
Primary outcome: Primary: Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. — 99 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Jan 2014
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 | — |
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.
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.