Intracranial Atherosclerosis
Conditions
Keywords
Wingspan Stent System, Wingspan Stent, Intracranial Stent, Ischemic Stroke, Intracranial Atherosclerotic Disease, Intracranial Stenosis
Brief summary
The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.
Detailed description
This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.
Interventions
DEVICEWingspan Stent System
The Wingspan Stent System is used with the Gateway PTA Balloon Catheter. The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon Catheter is an over-the-wire balloon catheter intended for the pre-dilation of the lesion prior to insertion and deployment of the Wingspan Stent System.
Sponsors
Stryker Neurovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
All patients for whom treatment with the Wingspan Stent System is considered.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Stroke or Death Among Participants | within 72 hours of the procedure | The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Ischemic Stroke Among Participants | within 72 hours post procedure | Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic etiology and is detectable on examination at least 24 hours after onset of symptoms. |
| Rate of Neurological Death Among Participants | within 72 hours post procedure | A diagnosis of death by neurological criteria |
| Rate of Stroke Recovery Among Participants | at 90 days post procedure | Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90. |
| Rate of Stroke in the Territory of the Stented Artery Among Participants | within 72 hours post procedure | Stroke in the vascular territory of the stented artery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stenting Prospective, single-arm, consecutive enrollment, post market surveillance study of patients who have a Wingspan stent procedure attempted. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
Baseline characteristics
| Characteristic | Stenting |
|---|---|
| Age, Continuous | 61.89 years STANDARD_DEVIATION 10.52 |
| Baseline modified Rankin Scale 0 | 20 Participants |
| Baseline modified Rankin Scale 1 | 37 Participants |
| Baseline modified Rankin Scale 2 | 52 Participants |
| Baseline modified Rankin Scale 3 | 43 Participants |
| Baseline modified Rankin Scale 4 | 0 Participants |
| Baseline modified Rankin Scale 5 | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American or Black | 30 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 101 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiracial | 5 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 152 |
| other Total, other adverse events | 12 / 152 |
| serious Total, serious adverse events | 9 / 152 |
Outcome results
Primary
Rate of Stroke or Death Among Participants
The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.
Time frame: within 72 hours of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenting | Rate of Stroke or Death Among Participants | 4 Participants |
Secondary
Rate of Ischemic Stroke Among Participants
Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic etiology and is detectable on examination at least 24 hours after onset of symptoms.
Time frame: within 72 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenting | Rate of Ischemic Stroke Among Participants | 1 Participants |
Secondary
Rate of Neurological Death Among Participants
A diagnosis of death by neurological criteria
Time frame: within 72 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenting | Rate of Neurological Death Among Participants | 2 Participants |
Secondary
Rate of Stroke in the Territory of the Stented Artery Among Participants
Stroke in the vascular territory of the stented artery
Time frame: within 72 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenting | Rate of Stroke in the Territory of the Stented Artery Among Participants | 4 Participants |
Secondary
Rate of Stroke Recovery Among Participants
Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.
Time frame: at 90 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenting | Rate of Stroke Recovery Among Participants | 0 Participants |