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The Intra-arterial Vasospasm Trial (iVAST)

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ClinicalTrials.gov Identifier: NCT01996436
Recruitment Status : Recruiting
First Posted : November 27, 2013
Last Update Posted : January 5, 2022
Sponsor:
Collaborators:
Yale University
Thomas Jefferson University
University of Illinois at Chicago
Wake Forest University Health Sciences
Temple University
Geisinger Clinic
Northwell Health
University of Michigan
Lenox Hill Hospital
Weatherhead
Information provided by (Responsible Party):
Peng Roc Chen, The University of Texas Health Science Center, Houston

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cerebral Vasospasm Drug: Nicardipine Drug: Verapamil Drug: Nicardipine + Verapamil + Nitroglycerin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Intra-arterial Vasospasm Trial(iVAST)- A Multi-center Randomized Study
Actual Study Start Date : August 29, 2016
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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

    A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter

    PIIR across all four treatment arms will be compared and tested for statistical significance.



Secondary Outcome Measures :
  1. To grade clinical outcome using Modified Rankin score [ Time Frame: 3 months post discharge from hospital ]
    Clinical outcome at 3 months post discharge from hospital after treatment will be evaluated using Modified Rankin score


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996436


Contacts
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Contact: Peng R Chen, MD 713-486-8016 Peng.R.Chen@uth.tmc.edu
Contact: Eddie Aguilar, BA 713-486-7764 Eddie.Aguilar@uth.tmc.edu

Locations
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United States, Connecticut
Yale School of Medicine Terminated
New Haven, Connecticut, United States, 06520
United States, Illinois
University of Illinois College of Medicine at Chicago Withdrawn
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan Withdrawn
Ann Arbor, Michigan, United States, 48109
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: David Ledoux, MD    516-562-3590      
Contact: Sarah Nazir       snazir1@northwell.edu   
Lenox Hill Withdrawn
New York, New York, United States, 10065
United States, North Carolina
Wake Forest University Health Sciences Terminated
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Geisinger Clinic Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Clemens Schirmer, MD         
Contact: Chelsea Derr       cmderr1@geisinger.edu   
Thomas Jefferson University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Temple University Withdrawn
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
University of Texas Medical School at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Sunil Sheth, MD       Sunil.A.Sheth@uth.tmc.edu   
Contact: Eddie Aguilar, BA    713-486-7764    Eddie.Aguilar@uth.tmc.edu   
Principal Investigator: Sunil Sheth, MD         
Sponsors and Collaborators
Peng Roc Chen
Yale University
Thomas Jefferson University
University of Illinois at Chicago
Wake Forest University Health Sciences
Temple University
Geisinger Clinic
Northwell Health
University of Michigan
Lenox Hill Hospital
Weatherhead
Investigators
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Principal Investigator: Peng R Chen, MD University of Texas Medical School at Houston
Principal Investigator: Ketan R Bulsara, MD, MBA UConn Health
Publications:

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Responsible Party: Peng Roc Chen, Professor in Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01996436    
Other Study ID Numbers: IVT_201310 (HSC-MS-13-0586)
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peng Roc Chen, The University of Texas Health Science Center, Houston:
cerebral vasospasm
aneurysmal subarachnoid hemorrhage
intra arterial drug treatment for cerebral vasospasm
nicardipine milrinone nitroglycerin verapamil
Additional relevant MeSH terms:
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Vasospasm, Intracranial
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Verapamil
Nicardipine
Nitroglycerin
Vasodilator Agents
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antihypertensive Agents