The Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis Trial: Reanalysis Using the FDA “On Label” Criteria

Author:

Qureshi Adnan I.12,Ishfaq Muhammad F.13ORCID,Balasetti Vamshi K. S.2,Lobanova Iryna12ORCID,Uzun Guven12,Siddiq Farhan2,Gomez Camilo R.2ORCID

Affiliation:

1. Zeenat Qureshi Stroke Institute St. Cloud MN

2. Division of Neurosurgery, Department of Neurology University of Missouri Columbia MO

3. Department of Neurology University of Tennessee Memphis TN

Publisher

Wiley

Subject

Neurology (clinical),Radiology, Nuclear Medicine and imaging

Reference18 articles.

1. Humanitarian Device Exemption (HDE). Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H050001. Accessed March 05 2020.

2. A Novel, Self-Expanding, Nitinol Stent in Medically Refractory Intracranial Atherosclerotic Stenoses

3. Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis

4. FDA revises indications for use of Stryker's Wingspan stent system. Available at:https://evtoday.com/2012/08/08/fda-revises-indications-for-use-of-strykers-wingspan-stent-system?center=126. Accessed March 05 2020.

5. WEAVE Trial

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