Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) Trial in Symptomatic Intracranial Stenosis

Background Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; ho...

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Published in:Journal of stroke and cerebrovascular diseases 2013-10, Vol.22 (7), p.1131-1139
Main Authors: Zaidat, Osama O., MD, MS, Castonguay, Alicia C., PhD, Fitzsimmons, Brian-Fred, MD, Woodward, Britton Keith, MD, Wang, Zhigang, MD, Killer-Oberpfalzer, Monika, MD, Wakhloo, Ajay, MD, PhD, Gupta, Rishi, MD, Kirshner, Howard, MD, Eliasziw, Misha, PhD, Thomas Megerian, J., MD, PhD, Shetty, Sujith, MBBS, Yoklavich Guilhermier, Meg, Barnwell, Stanley, MD, Smith, Wade S., MD, Gress, Daryl R., MD
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
angioplasty
balloon-mounted stent
Cardiovascular
Clinical Protocols
clinical trial
Constriction, Pathologic - surgery
endovascular
Female
Humans
Intracranial Arteriosclerosis - complications
Intracranial Arteriosclerosis - surgery
intracranial stenosis
intracranial stent
ischemic stroke
Male
Middle Aged
Neurology
PHAROS stent
Research Design
Stents - adverse effects
stroke
Stroke - etiology
Stroke - prevention & control
transient ischemic attack
VISSIT
Vitesse stent
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Summary:Background Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.
ISSN:1052-3057
1532-8511
DOI:10.1016/j.jstrokecerebrovasdis.2012.10.021