Carotid Artery Stenosis
Conditions
Keywords
carotid artery stenosis, embolic protection device, distal embolic filter, minimizing risks of carotid artery stenting
Brief summary
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
Detailed description
Continuous advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made CAS a viable alternative to CEA. Advances in embolic protection technology will assist in moving CAS forward as a universally accepted procedure. While the GORE® Embolic Filter is similar in many ways to other currently available filters, it has been designed to provide optimal vessel wall apposition. Bench tests suggest that the wall apposition may provide improved filter efficiency, thereby minimizing embolization of particles downstream and potentially decreasing adverse clinical effects. In addition, preclinical testing suggests that the GORE® Embolic Filter has improved deliverability, including torque ability and lesion cross that may improve the ability of the system to access and treat tight lesions in tortuous anatomy. Thus, the purpose of this multi-center clinical study is to assess the safety and effectiveness of the GORE® Embolic Filter when used to provide cerebral embolic protection during carotid artery angioplasty and stenting.
Interventions
DEVICEGORE® Embolic Filter
Embolic protection during carotid stenting
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
1. Subject is either: * Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR * Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology 2. Target lesion is located in one of the following: * ICA * bifurcation * CCA proximal to the bifurcation 3. 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 |
|---|---|
| Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic Events | 30 days | Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs). |
| Device Success | Post Procedure | Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use). |
| Clinical Success | 30 days | Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure. |
| Access Site Complications | 30 days | Access Site Complications defined as the presence of a large hematoma (\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure. |
Participant flow
Recruitment details
This study will be conducted at a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices) and will enroll approximately 250 subjects.
Participants by arm
| Arm | Count |
|---|---|
| EMBOLDEN GORE® Embolic Filter with carotid artery stenting | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 30 Days Post-Procedure | Discontinued | 7 |
| 30 Days Post-Procedure | Missed Visit - No Phone Contact | 1 |
| 30 Days Post-Procedure | Missed Visit - Phone Contact f/u | 4 |
Baseline characteristics
| Characteristic | EMBOLDEN |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 206 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 74.7 Years |
| History of Diabetes No | 163 Participants |
| History of Diabetes Yes | 87 Participants |
| History of Hypertension No | 14 Participants |
| History of Hypertension Yes | 236 Participants |
| History of Ischemic Stroke None | 200 Participants |
| History of Ischemic Stroke One | 34 Participants |
| History of Ischemic Stroke Two or More | 12 Participants |
| History of Ischemic Stroke Unknown | 4 Participants |
| Previous Endarterectomy 1 Year or Greater | 63 Participants |
| Previous Endarterectomy Less than 1 Year | 13 Participants |
| Previous Endarterectomy None | 171 Participants |
| Previous Endarterectomy Unknown | 3 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 153 Participants |
| Symptomatology Asymptomatic | 213 Participants |
| Symptomatology Symptomatic | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 250 |
| serious Total, serious adverse events | 56 / 250 |
Outcome results
Primary
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Time frame: 30 days
Population: EMBOLDEN subjects evaluable for the primary endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Myocardial Infarction (MI - Overall) | 1 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Q-Wave MI | 0 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Subjects With One or More Major Adverse Events | 10 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Death | 2 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Non-Q-Wave MI | 1 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Stroke (Overall) | 7 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Major Stroke (Overall) | 1 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Ischemic Stroke (Major) | 1 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Hemorrhagic Stroke (Major) | 0 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Minor Stroke (Overall) | 6 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Ischemic Stroke (Minor) | 6 Participants |
| EMBOLDEN | Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure | Hemorrhagic Stroke (Minor) | 0 Participants |
Comparison: This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025.p-value: 0.000195% CI: [0.021, 0.077]One Sample Binomial
Secondary
Access Site Complications
Access Site Complications defined as the presence of a large hematoma (\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBOLDEN | Access Site Complications | 6 Participants |
Secondary
Clinical Success
Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBOLDEN | Clinical Success | 233 Participants |
Secondary
Device Success
Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).
Time frame: Post Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBOLDEN | Device Success | 241 Participants |
Secondary
Neurologic Events
Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EMBOLDEN | Neurologic Events | 16 Participants |