Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) Trial in Symptomatic Intracranial Stenosis
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, eval...
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| Published in | Journal of stroke and cerebrovascular diseases Vol. 22; no. 7; pp. 1131 - 1139 |
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| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.10.2013
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| Subjects | |
| Online Access | Get full text |
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| Abstract | 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.
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.
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.
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. |
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| AbstractList | 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.BACKGROUNDPatients 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.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.METHODSThe 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.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.RESULTSEnrollment 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.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.CONCLUSIONSThe 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. |
| Author | Kirshner, Howard Woodward, Britton Keith Wang, Zhigang Barnwell, Stanley Thomas Megerian, J. Shetty, Sujith Gress, Daryl R. Castonguay, Alicia C. Wakhloo, Ajay Killer-Oberpfalzer, Monika Fitzsimmons, Brian-Fred Gupta, Rishi Smith, Wade S. Zaidat, Osama O. Yoklavich Guilhermier, Meg Eliasziw, Misha |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23261207$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1007_s11936_015_0369_y crossref_primary_10_1080_14737175_2016_1179111 crossref_primary_10_1161_STROKEAHA_113_001290 crossref_primary_10_1136_neurintsurg_2013_011019 crossref_primary_10_3389_fneur_2018_00666 crossref_primary_10_1007_s11886_013_0422_y crossref_primary_10_1161_STROKEAHA_114_005975 crossref_primary_10_1177_17562864221114716 crossref_primary_10_1016_j_jstrokecerebrovasdis_2018_12_039 crossref_primary_10_3389_fneur_2014_00129 crossref_primary_10_1017_S0266462317000411 crossref_primary_10_1089_ther_2013_1512 crossref_primary_10_3389_fneur_2020_620031 crossref_primary_10_1161_CIRCRESAHA_116_308441 crossref_primary_10_1016_j_jstrokecerebrovasdis_2018_02_050 crossref_primary_10_1097_CRD_0000000000000663 crossref_primary_10_3389_fneur_2014_00246 |
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| Copyright | 2013 National Stroke Association National Stroke Association Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved. |
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| Keywords | Vitesse stent clinical trial VISSIT endovascular intracranial stent PHAROS stent intracranial stenosis transient ischemic attack stroke balloon-mounted stent ischemic stroke angioplasty |
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| PublicationDecade | 2010 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Journal of stroke and cerebrovascular diseases |
| PublicationTitleAlternate | J Stroke Cerebrovasc Dis |
| PublicationYear | 2013 |
| Publisher | Elsevier Inc |
| Publisher_xml | – name: Elsevier Inc |
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| Snippet | Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or... Background Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with... Patients with high-grade symptomatic intracranial stenosis (≥ 70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or... |
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| SubjectTerms | 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 |
| Title | Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) Trial in Symptomatic Intracranial Stenosis |
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