The Intra-arterial Vasospasm Trial

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