Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)

Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN)

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Atherosclerotic Disease (ICAD)

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

152 patients stented on-label in the WEAVE trial.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	1 year

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Michael J Alexander, MD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: N Engl J Med. 2012 Jul 5;367(1):93.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ACTUAL): May 19, 2020
• Study Completion (ACTUAL): May 19, 2020

Study Registration Dates

• First Submitted: January 4, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No