The Intra-arterial Vasospasm Trial (iVAST)

April 29, 2025 updated by: Peng Roc Chen, MD

The Intra-arterial Vasospasm Trial - 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Medical School at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nicardipine
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Drug: Nicardipine
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
Other Names:
  • Cardene
Active Comparator: Verapamil
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Drug: Verapamil
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
Active Comparator: Nicardipine + Verapamil + Nitroglycerin
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Drug: Nicardipine + Verapamil + Nitroglycerin
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Infusion Improvement Ratio (PIIR)
Time Frame: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion

Post infusion improvement ratio (PIIR) = ((B - A) / A) *100

A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score
Time Frame: 3 months post discharge from hospital

The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

The Modified Rankin Score (mRS) is scored as follows:

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
3 months post discharge from hospital

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-cranial Pressure
Time Frame: 1 day prior to procedure & 1 day after the procedure
Intra-cranial pressure will be measured 1 day prior to vasospasm treatment and 1 day after vasospasm treatment
1 day prior to procedure & 1 day after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peng Roc Chen, MD

Collaborators

Yale University
Northwell Health
University of Michigan
University of Illinois at Chicago
Wake Forest University Health Sciences
University of California, Irvine
Temple University
Thomas Jefferson University
Geisinger Clinic
Lenox Hill Hospital
Weatherhead Foundation

Investigators

  • Principal Investigator: Peng R Chen, MD, University of Texas Medical School at Houston
  • Principal Investigator: Ketan R Bulsara, MD, MBA, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2016

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimated)

November 27, 2013

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVT_201310 (HSC-MS-13-0586)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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