Clinical trial NCT04221984: Wingspan One Year Vascular Imaging Events and Neurologic Outcomes
Official title: Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Atherosclerotic Disease (ICAD)
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 152 patients stented on-label in the WEAVE trial.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for this study are the 152 patients stented in the WEAVE trial on-label.

The patients had the following inclusion criteria:

* Age 18-80
* Intracranial artery stenosis greater or equal to 70% stenosis
* Target artery 2 mm or larger
* Presented with stroke while on medical therapy for stroke prevention
* Prior stroke in the target territory
* Modified Rankin Score of 3 or better (neurologic function)
* Treated greater than 7 days after their last stroke
* Treated with the Wingspan stent by an approved trial NeuroInterventionalist

Exclusion Criteria:

* Patients treated outside of the trial or who did not meet the entry criteria.
* Patients that had stent treatment for arterial dissection
* Patients that had extra-cranial stenosis
* Patients outside the age range of the study
* Patients treated less than 8 days from their stroke.

Primary outcomes:
measure: 1-year stroke rate following placement of Wingspan stent in this patient cohort
timeFrame: 1 year
measure: 1-year death rate following placement of Wingspan stent in this patient cohort
timeFrame: 1 year
Secondary outcomes:
measure: Symptomatic re-stenosis rates of the patient group.
timeFrame: 1 year
measure: Severity of the strokes/index event that occurred in that patient group.
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Michael J Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.