The Intra-arterial Vasospasm Trial (iVAST)
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| ClinicalTrials.gov Identifier: NCT01996436 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2013
Last Update Posted : January 5, 2022
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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 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Nicardipine
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
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Drug: Nicardipine
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
Other Name: Cardene |
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Active Comparator: Verapamil
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
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Drug: Verapamil
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm |
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Active Comparator: Nicardipine + Verapamil + Nitroglycerin
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
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Drug: Nicardipine + Verapamil + Nitroglycerin
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm |
- 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.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Peng R Chen, MD | University of Texas Medical School at Houston | |
| Principal Investigator: | Ketan R Bulsara, MD, MBA | UConn Health |
| 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 |
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cerebral vasospasm aneurysmal subarachnoid hemorrhage intra arterial drug treatment for cerebral vasospasm nicardipine milrinone nitroglycerin verapamil |
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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 |