The Intra-arterial Vasospasm Trial (iVAST)

Peng Roc Chen, MD

Status and phase: Enrolling; Phase 4

Conditions: Cerebral Vasospasm

Treatments: Drug: Nicardipine + Verapamil + Nitroglycerin; Drug: Nicardipine; Drug: Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT01996436

IVT_201310 (HSC-MS-13-0586)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.
• Symptomatic vasospasm (clinical or TCD)
• For centers that perform a routine day 7 angiogram post-aneurysm treatment - 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.

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
• Intra-arterial drug treatment in all 3 arterial territories

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups

Nicardipine

Active Comparator group

Description:

Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty

Treatment:

Drug: Nicardipine

Verapamil

Active Comparator group

Description:

Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty

Treatment:

Drug: Verapamil

Nicardipine + Verapamil + Nitroglycerin

Active Comparator group

Description:

Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty

Treatment:

Drug: Nicardipine + Verapamil + Nitroglycerin