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The purpose of the study is to determine the one-year post stenting outcomes in patients who were treated with the Wingspan stent on-label in the WEAVE trial. This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients.
The current study is a retrospective chart and imaging review of the 152 patients enrolled in the WEAVE trial to determine the one-year outcomes for these patients.
This includes both the assessment of any stroke, hemorrhage, or death, as well as assessment of delayed imaging results to determine the re-stenosis rate of the stents in these patients and the medication regimen in those patients who had symptomatic re-stenosis.
The subjects for this study are pre-defined as the 152 patients who had placement of a Wingspan stent for treatment of their intracranial artery stenosis that had symptoms of stroke and 70% or greater arterial stenosis. The study will be conducted at 24 sites in the United States. It is expected that up to 152 patients' records will be assessed for follow up data analysis. Patient's information will be included in the study if they were enrolled in the WEAVE Trial and had placement of a Wingspan stent in its on-label usage indication between 12/1/2013 and 10/31/2017. Follow up information from the patients' charts will be extracted out to the one-year interval following stenting up to December 2018.
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| Measure | Description | Time Frame |
|---|---|---|
| 1-year stroke rate following placement of Wingspan stent in this patient cohort | 1-year stroke rate following placement of Wingspan stent in this patient cohort | 1 year |
| 1-year death rate following placement of Wingspan stent in this patient cohort | 1-year death rate following placement of Wingspan stent in this patient cohort | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic re-stenosis rates of the patient group. | Symptomatic re-stenosis rates of the patient group. | 1 year |
| Severity of the strokes/index event that occurred in that patient group. | Severity of the strokes/index event that occurred in that patient group. |
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Inclusion Criteria:
The patients had the following inclusion criteria:
Exclusion Criteria:
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152 patients stented on-label in the WEAVE trial.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Alexander, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31125298 | Background | 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. | |
| 17395864 | Background | Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. doi: 10.1161/STROKEAHA.106.477711. Epub 2007 Mar 29. |
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| 1 year |
| 21899409 | Background | Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7. |