The Intra-arterial Vasospasm Trial



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:5/10/2018
Start Date:August 2016
End Date:December 2020
Contact:Peng R Chen, MD
Email:Peng.R.Chen@uth.tmc.edu
Phone:713-704-7100

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The Intra-arterial Vasospasm Trial(iVAST)- A Multi-center Randomized Study

The primary objective of the study is to determine the optimal intra-arterial drug treatment
regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal
subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days
post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.

We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is
more efficacious than single agent treatment cerebral vasospasm therapy.

All procedures done as a part of this study are standard hospital care procedures done to
treat cerebral vasospasm and all drugs to be used are FDA approved.

The primary objective of the study is to determine the optimal intra-arterial drug treatment
regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal
subarachnoid hemorrhage.

The secondary objective is to evaluate clinical outcome at 90 days post discharge following
optimal intra-arterial drug treatment for cerebral vasospasm.

This study is a prospective multicenter randomized trial. The primary outcome measure is the
Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the
intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post
intra-arterial drug infusion in the presenting vasospasmic blood vessel.

Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a
secondary outcome to assess clinical outcome.

The interventions in this study are a part of routine standard of care (SOC) procedures for
cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal
Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal
medical management, endovascular treatment by intra-arterial drug infusion of single drug
agent or cocktail drug agents will be initiated.

Study participants will be randomly assigned to one of the three treatment groups where one
single drug agent or cocktail drug agents will be intra-arterially administered. Pre & post
infusion vasospasmic vessel diameters will be compared. The change in diameter will be
quantified based on the mean percentage change. Three months post hospital discharge, study
participants will be followed up in clinic to evaluate clinical outcome.

The study will require 330 patients in total. The patient population will be hospitalized
patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage.

Subjects will be stratified by randomization into 3 treatment groups.

Inclusion Criteria:

- Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral
vasospasm post operatively within 3-21 days.

Exclusion Criteria:

- Inability to obtain consent from patient or patients kin

- Pregnant women

- less than 18 years of age of more than 80 years of age

- Hunt Hess Grade 5 SAH
We found this trial at
10
sites
Houston, Texas 77030
Principal Investigator: Sunil Sheth, MD
Phone: 713-704-7100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-615-4486
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Chicago, Illinois 60612
Principal Investigator: Ali Alaraj, MD
Phone: 312-996-4842
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Danville, Pennsylvania 17882
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Manhasset, New York 11030
Phone: 516-562-3590
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New Haven, Connecticut 06520
Principal Investigator: Nils Petersen, MD
Phone: 203-737-2096
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New York, New York 10075
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Pascal M Jabbour, MD
Phone: 215-955-7000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Phone: 617-697-4722
Temple University Temple University is many things to many people. A place to pursue life's...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Phone: 336-716-3842
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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