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Completed

NCT Number: NCT04221984

Wingspan One Year Vascular Imaging Events and Neurologic Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 1-year stroke rate following placement of Wingspan stent in this patient cohort

    Time frame: 1 year

    1-year stroke rate following placement of Wingspan stent in this patient cohort

  2. 1-year death rate following placement of Wingspan stent in this patient cohort

    Time frame: 1 year

    1-year death rate following placement of Wingspan stent in this patient cohort

Secondary outcomes

  1. Symptomatic re-stenosis rates of the patient group.

    Time frame: 1 year

    Symptomatic re-stenosis rates of the patient group.

  2. Severity of the strokes/index event that occurred in that patient group.

    Time frame: 1 year

    Severity of the strokes/index event that occurred in that patient group.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: WOVEN

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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