Arterial Occlusive Diseases, Brain Diseases, Cardiovascular Diseases, Carotid Artery Diseases, Carotid Stenosis, Central Nervous System Diseases, Cerebrovascular Disorders, Constriction, Pathologic, Nervous System Diseases, Pathological Conditions, Anatomical, Vascular Diseases
Conditions
Keywords
GORE Neuro Protection System, GORE Flow Reversal System, carotid artery stenosis, embolic protection device, reverse flow, proximal occlusion device, GNPS, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES, embolic filter
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.
Interventions
DEVICEGore Embolic Filter
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
DEVICEGore Flow Reversal System
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events (MAE) | Onset from start of index procedure to 30-day follow-up assessment | Major Adverse Events include death, stroke and myocardial infarction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GFRS EPD Carotid artery stenting with Gore Flow Reversal System
Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting | 425 |
| GEF EPD Carotid artery stenting with Gore Embolic Filter
Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting | 972 |
| Total | 1,397 |
Baseline characteristics
| Characteristic | GEF EPD | Total | GFRS EPD |
|---|---|---|---|
| Age, Continuous | 73.0 years STANDARD_DEVIATION 9.4 | 72.9 years STANDARD_DEVIATION 9.2 | 72.7 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 27 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 955 Participants | 1369 Participants | 414 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 9 participants | 17 participants | 8 participants |
| Race/Ethnicity, Customized Asian | 8 participants | 15 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 56 participants | 82 participants | 26 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Not Reported | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized White or Caucasian | 901 participants | 1282 participants | 381 participants |
| Sex: Female, Male Female | 587 Participants | 726 Participants | 139 Participants |
| Sex: Female, Male Male | 385 Participants | 671 Participants | 286 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 425 | 0 / 972 |
| serious Total, serious adverse events | 18 / 425 | 36 / 972 |
Outcome results
Primary
Major Adverse Events (MAE)
Major Adverse Events include death, stroke and myocardial infarction
Time frame: Onset from start of index procedure to 30-day follow-up assessment
Population: Enrolled subjects with successful procedure and sufficient follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS EPD | Major Adverse Events (MAE) | 18 participants |
| GEF EPD | Major Adverse Events (MAE) | 36 participants |