NCT04221984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

January 4, 2020

Last Update Submit

July 27, 2021

Conditions

Intracranial Atherosclerotic Disease (ICAD)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Symptomatic re-stenosis rates of the patient group.

    1 year

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

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

152 patients stented on-label in the WEAVE trial.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

  • 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.

    PMID: 31125298BACKGROUND

  • 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.

    PMID: 17395864BACKGROUND

  • 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.

    PMID: 21899409BACKGROUND

Study Officials

  • Michael J Alexander, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chairman, Department of Neurosurgery, Director of the Cedars-Sinai Neurovascular Center, Co-Director, Comprehensive Stroke Center

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 9, 2020

Study Start

November 12, 2019

Primary Completion

May 19, 2020

Study Completion

May 19, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)