Carotid Artery Stenosis
Conditions
Keywords
carotid artery stenosis, embolic protection device, GORE Neuro Protection System, GORE Flow Reversal System, reverse flow, proximal occlusion device, GNPS, Parodi, EMPiRE, distal embolization, minimizing risks of CAS, PAES
Brief summary
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
Detailed description
The GORE Flow Reversal System, manufactured by W. L. Gore & Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence. The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.
Interventions
DEVICEGORE Flow Reversal System (GFRS)
Carotid artery angioplasty and stenting with embolic protection
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80% * Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation * At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)
Exclusion criteria
* Recent surgical procedure within 30 days before or after the stent procedure * Uncontrolled sensitivity to contrast media * Renal Insufficiency * Recent evolving, acute stroke within 21 days of study evaluation * Myocardial infarction within 72 hours prior to stent procedure * History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS) * Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Major Adverse Event (MAE) Rate | Treatment through 30-day visit window | Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow Reversal System Technical Success | Procedure | Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure) |
| Flow Reversal System Success | Procedure | Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure. |
| Stent Success | Procedure | Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of \< 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory. |
| Clinical Success | 24-48 Hours Post-Procedure | Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC). |
| Patency at 30 Days | Treatment through 30-day visit window | Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure. |
Countries
United States
Participant flow
Recruitment details
The study was approved to enroll subjects from a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices).
Participants by arm
| Arm | Count |
|---|---|
| GFRS Pivotal Subjects All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases). | 245 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up Through 30 Days Post Procedure | Death / Reintervention / Medical Reasons | 2 |
| Follow-up Through 30 Days Post Procedure | Discontinued Prior to Visit | 6 |
| Follow-up Through 30 Days Post Procedure | Missed Visit - Phone Contact Follow-up | 4 |
| Procedure | Technical Failure | 9 |
Baseline characteristics
| Characteristic | GFRS Pivotal Subjects |
|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 9.6 |
| Age, Customized < 80 years | 207 participants |
| Age, Customized >= 80 years | 38 participants |
| History of Diabetes No | 159 participants |
| History of Diabetes Yes | 86 participants |
| History of Hypertension No | 33 participants |
| History of Hypertension Yes | 212 participants |
| History of Ischemic Stroke None | 192 participants |
| History of Ischemic Stroke One | 42 participants |
| History of Ischemic Stroke Two or More | 11 participants |
| Previous Endarterectomy Greater than 1 Year | 79 participants |
| Previous Endarterectomy Less than 1 Year | 23 participants |
| Previous Endarterectomy None | 143 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 165 Participants |
| Symptomatic Asymptomatic | 167 participants |
| Symptomatic Symptomatic | 78 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 62 / 245 |
| serious Total, serious adverse events | 40 / 245 |
Outcome results
Primary
Composite Major Adverse Event (MAE) Rate
Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)
Time frame: Treatment through 30-day visit window
Population: All primary endpoint evaluable subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Major Ischemic Stroke | 0 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Minor Ischemic Stroke | 5 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Hemorrhagic Stroke | 2 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Death | 2 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Death / Any Stroke | 7 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Myocardial Infarction (MI) | 2 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Death / Stroke / MI | 9 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Transient Ischemic Attack (TIA) | 2 participants |
| GFRS Pivotal Subjects | Composite Major Adverse Event (MAE) Rate | Overall MAE | 11 participants |
Comparison: The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.p-value: 0.00295% CI: [0.027, 0.095]One-Sample Binomial
Secondary
Clinical Success
Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).
Time frame: 24-48 Hours Post-Procedure
Population: All enrolled subjects with post procedure angiographic assessment of lesion stenosis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS Pivotal Subjects | Clinical Success | 211 participants |
Secondary
Flow Reversal System Success
Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.
Time frame: Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS Pivotal Subjects | Flow Reversal System Success | 233 participants |
Secondary
Flow Reversal System Technical Success
Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)
Time frame: Procedure
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS Pivotal Subjects | Flow Reversal System Technical Success | 236 participants |
Secondary
Patency at 30 Days
Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.
Time frame: Treatment through 30-day visit window
Population: Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS Pivotal Subjects | Patency at 30 Days | 182 participants |
Secondary
Stent Success
Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of \< 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.
Time frame: Procedure
Population: All enrolled subjects with post procedure angiographic assessment of lesion stenosis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GFRS Pivotal Subjects | Stent Success | 228 participants |