Carotid Artery Disease, Carotid Artery Stenosis
Conditions
Keywords
Stroke, Carotid Artery Stenting (CAS), Embolic Protection Device (EPD), Stent, 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, Angioplasty
Brief summary
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
Detailed description
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.
Interventions
DEVICECarotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
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
* Patient is at least 18 years old at informed consent * Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone. * Patient is willing to provide written informed consent prior to enrollment in study. * Patient is either: * Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR * Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology * Patient must be considered high risk for adverse events during carotid endarterectomy Note: Additional inclusion criteria may apply
Exclusion criteria
* Patient has life expectancy of less than one year. * Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke. * Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months). * Patient has had an acute myocardial infarction within 72 hours prior to the index procedure. * Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments. * Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure. Note: Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Major Adverse Events (MAE) at One Year | 365 days | MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success | Procedural | EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods. |
| Number of Participants Who Achieved Procedure Success | Procedural | Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE. |
| Number of Participants Who Experienced MAE at 30 Days | 30 days | Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure. |
| 30-Day MAE - Death | 30 days | Any cause death through 30 days post-index procedure |
| Number of Participants Who Achieved Stent Technical Success | Procedural | Stent Technical Success defined as successful implantation of a GORE® Carotid Stent |
| 30-Day MAE - Stroke | 30 days | Any stroke through 30 days post-index procedure |
| In-Stent Restenosis | 365 days | ≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis |
| Target Lesion Revascularization | 365 days | Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion |
| 30-Day MAE - Myocardial Infarction | 30 days | Any myocardial infarction through 30 days post-index procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carotid Artery Stenting Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent | 265 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1-Year (365-Day) MAE Evaluation | Death | 7 |
| 1-Year (365-Day) MAE Evaluation | Insufficient Follow-up | 6 |
| 1-Year (365-Day) MAE Evaluation | Lost to Follow-up | 5 |
| 1-Year (365-Day) MAE Evaluation | Withdrawal by Subject | 2 |
| 30-Day MAE Evaluation | Insufficient Follow-up | 1 |
| Screening Committee Retrospective Review | Protocol Violation | 47 |
Baseline characteristics
| Characteristic | Carotid Artery Stenting |
|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 8.8 |
| Cigarette Smoking Current or stopped <12 months ago | 67 Participants |
| Cigarette Smoking Never | 59 Participants |
| Cigarette Smoking Previous (stopped >12 months ago) | 139 Participants |
| Diabetes Mellitus | 107 Participants |
| Endarterectomy | 79 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 258 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| History of Ischemic Stroke | 48 Participants |
| History of Transient Ischemic Attack (TIA) | 40 Participants |
| Hypertension | 249 Participants |
| Ipsilateral Amaurosis Fugax or Transient Monocular Blindness (TMB) | 9 Participants |
| Previous Carotid Disease | 125 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 252 Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 176 Participants |
| Symptomatic | 33 Participants |
| Target Lesion % Diameter Stenosis | 85 percentage of vessel diameter |
| Target Lesion Length (mm) | 20 millimeters |
| Target Lesion Location Bifurcation | 30 Participants |
| Target Lesion Location ICA | 235 Participants |
| Target Vessel Reference Diameter (mm) | 5.5 millimeters |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 265 |
| other Total, other adverse events | 110 / 265 |
| serious Total, serious adverse events | 104 / 265 |
Outcome results
Primary
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
Time frame: 365 days
Population: Per protocol subjects with 1-year MAE evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Number of Participants Who Experienced Major Adverse Events (MAE) at One Year | 11 Participants |
Comparison: Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1.p-value: <0.00001Binomial test (normal approximation)
Secondary
30-Day MAE - Death
Any cause death through 30 days post-index procedure
Time frame: 30 days
Population: Per protocol subjects with 30-day MAE evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | 30-Day MAE - Death | 1 Participants |
Secondary
30-Day MAE - Myocardial Infarction
Any myocardial infarction through 30 days post-index procedure
Time frame: 30 days
Population: Per protocol subjects with 30-day MAE evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | 30-Day MAE - Myocardial Infarction | 4 Participants |
Secondary
30-Day MAE - Stroke
Any stroke through 30 days post-index procedure
Time frame: 30 days
Population: Per protocol subjects with 30-day MAE evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | 30-Day MAE - Stroke | 3 Participants |
Secondary
In-Stent Restenosis
≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis
Time frame: 365 days
Population: Per protocol subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | In-Stent Restenosis | 4 Participants |
95% CI: [0.007, 0.047]
Secondary
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.
Time frame: Procedural
Population: Per protocol subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success | 251 Participants |
Secondary
Number of Participants Who Achieved Procedure Success
Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE.
Time frame: Procedural
Population: Per protocol subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Number of Participants Who Achieved Procedure Success | 250 Participants |
Secondary
Number of Participants Who Achieved Stent Technical Success
Stent Technical Success defined as successful implantation of a GORE® Carotid Stent
Time frame: Procedural
Population: Per protocol subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Number of Participants Who Achieved Stent Technical Success | 265 Participants |
Secondary
Number of Participants Who Experienced MAE at 30 Days
Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.
Time frame: 30 days
Population: Per protocol subjects with 30-day MAE evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Number of Participants Who Experienced MAE at 30 Days | 8 Participants |
Secondary
Target Lesion Revascularization
Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Time frame: 365 days
Population: Per protocol subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carotid Artery Stenting | Target Lesion Revascularization | 5 Participants |
95% CI: [0.009, 0.052]