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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wingspan Stent System | Other | Placement of the Wingspan Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wingspan Stent System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 72 hours of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 72 hours post procedure |
| Rate of Neurological Death Among Participants |
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All patients for whom treatment with the Wingspan Stent System is considered.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Alexander, M.D. | Cedars-Sinai Medical Center | Principal Investigator |
| Wengui Yu, M.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Sutter Eden Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31125298 | Derived | Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenting | Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2016 |
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A diagnosis of death by neurological criteria |
| within 72 hours post procedure |
| Rate of Stroke Recovery Among Participants | Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90. | at 90 days post procedure |
| Rate of Stroke in the Territory of the Stented Artery Among Participants | Stroke in the vascular territory of the stented artery | within 72 hours post procedure |
| Castro Valley |
| California |
| 94546 |
| United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Emory University, Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| WellStar Health System | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Cadence Health, Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Massachusetts, Worcester | Worcester | Massachusetts | 01655 | United States |
| St. John Hospital and Medical Center, Inc. | Detroit | Michigan | 48236 | United States |
| SSM DePaul Health Center | Bridgeton | Missouri | 63044 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University Hospital of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97219 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Tennessee Interventional Associates | Chattanooga | Tennessee | 37403 | United States |
| Valley Baptist Harlingen | Harlingen | Texas | 78550 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| University of Washington, Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Multicare Medical Center | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stenting | Prospective, single-arm, consecutive enrollment, post market surveillance study of patients who have a Wingspan stent procedure attempted. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline modified Rankin Scale | mRS scale is as follows: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent" or similar). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | within 72 hours of the procedure |
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| 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. | Posted | Count of Participants | Participants | within 72 hours post procedure |
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| Secondary | Rate of Neurological Death Among Participants | A diagnosis of death by neurological criteria | Posted | Count of Participants | Participants | within 72 hours post procedure |
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| Secondary | Rate of Stroke Recovery Among Participants | Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90. | Posted | Count of Participants | Participants | at 90 days post procedure |
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| Secondary | Rate of Stroke in the Territory of the Stented Artery Among Participants | Stroke in the vascular territory of the stented artery | Posted | Count of Participants | Participants | within 72 hours post procedure |
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Serious and Other Adverse Events were monitored/assessed for up to 72 hours post-procedure. All-Cause Mortality was monitored/assessed through 90 days post procedure.
Only neurological AEs, bleeding/hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death experienced by the study subject after enrollment were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stenting | Prospective, single-arm, consecutive enrollment, post market surveillance study of patients treated with the Wingspan Stent System, according to the Indications for Use. | 3 | 152 | 9 | 152 | 12 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Craniocerebral injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
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| Neurological decompensation | Nervous system disorders | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site pain | General disorders | Systematic Assessment |
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| Application site haematoma | General disorders | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Muscular weakness | Nervous system disorders | Systematic Assessment |
| ||
| Neurological symptom | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alice Lin, Clinical Program Manager | Stryker Neurovascular | 510 413 2673 | alice.lin@stryker.com |
| Oct 10, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |
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| Hispanic or Latino |
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| Multiracial |
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| 3 |
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| 5 |
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