N/A
N=1,397
GORE Flow Reversal System and GORE Embolic Filter Extension Study
Carotid Stenosis · Constriction, Pathologic · Carotid Artery Diseases · Cerebrovascular Disorders · Brain Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01343667 ↗Enrolled (actual)
1,397
Serious AEs
3.9%
Results posted
Feb 2016
Primary outcome: Primary: Major Adverse Events (MAE) — 18; 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gore Flow Reversal System (Device); Gore Embolic Filter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Events (MAE) |
18; 36 | — |
Summary
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Eligibility Criteria
Inclusion Criteria
- Patient, or patient's legal representative, is able and willing to provide informed consent.
- Patient must be at least 18 years of age or older.
- Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU.
Exclusion Criteria
- Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected
If the patient is contraindicated for both arms (devices) they may not be enrolled.
Data sourced from ClinicalTrials.gov (NCT01343667). 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.