GORE Flow Reversal System and GORE Embolic Filter Extension Study

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure. This study is not designed to compare study endpoints between the two treatment arms.

Official Title
-----------------
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes

Conditions
-----------------
Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Arterial Occlusive Diseases, Vascular Diseases, Cardiovascular Diseases, Pathological Conditions, Anatomical

Intervention / Treatment
-----------------
* Device: Gore Flow Reversal System
* Device: Gore Embolic Filter


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GFRS EPD<br>Carotid artery stenting with Gore Flow Reversal System embolic protection device | Device: Gore Flow Reversal System<br>* Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting<br>* Other names: proximal protection;|
| Other: GEF EPD<br>Carotid artery stenting with Gore Embolic Filter embolic protection device | Device: Gore Embolic Filter<br>* Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting<br>* Other names: distal protection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAE) | Major Adverse Events include death, stroke and myocardial infarction | Onset from start of index procedure to 30-day follow-up assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GNPS, GORE Neuro Protection System, GORE Flow Reversal System, carotid artery stenosis, embolic protection device, reverse flow, proximal occlusion device, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES, embolic filter