The Intra-arterial Vasospasm Trial

Cerebral Vasospasm Clinical Trial

— iVAST  

Official title:

The Intra-arterial Vasospasm Trial(iVAST)- A Multi-center Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01996436
• Other study ID #: IVT_201310 (HSC-MS-13-0586)
• Status: Recruiting
• Phase: Phase 4
• Start date: August 29, 2016
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Peng R Chen, MD
• Phone: 713-486-8016
• Email: Peng.R.Chen[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Vasospasm, Intracranial

Intervention

Drug:
• Nicardipine
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
• Verapamil
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
• Nicardipine + Verapamil + Nitroglycerin
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Illinois College of Medicine at Chicago	Chicago	Illinois
United States	Geisinger Clinic	Danville	Pennsylvania
United States	University of Texas Medical School at Houston	Houston	Texas
United States	Northwell Health	Manhasset	New York
United States	Yale School of Medicine	New Haven	Connecticut
United States	Lenox Hill	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (11)

Lead Sponsor	Collaborator
Peng Roc Chen, MD	Geisinger Clinic, Lenox Hill Hospital, Northwell Health, Temple University, Thomas Jefferson University, University of Illinois at Chicago, University of Michigan, Wake Forest University Health Sciences, Weatherhead Foundation, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26. — View Citation

Biller J, Godersky JC, Adams HP Jr. Management of aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1300-5. doi: 10.1161/01.str.19.10.1300. No abstract available. — View Citation

Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. doi: 10.1016/0967-5868(94)90005-1. — View Citation

Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31. — View Citation

Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. doi: 10.1161/01.str.16.4.562. — View Citation

Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458. — View Citation

Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35. — View Citation

Pierot L, Aggour M, Moret J. Vasospasm after aneurysmal subarachnoid hemorrhage: recent advances in endovascular management. Curr Opin Crit Care. 2010 Apr;16(2):110-6. doi: 10.1097/MCC.0b013e3283372ef2. — View Citation

Treggiari MM, Walder B, Suter PM, Romand JA. Systematic review of the prevention of delayed ischemic neurological deficits with hypertension, hypervolemia, and hemodilution therapy following subarachnoid hemorrhage. J Neurosurg. 2003 May;98(5):978-84. doi: 10.3171/jns.2003.98.5.0978. Erratum In: J Neurosurg. 2003 Dec;99(6):1119. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-cranial pressure	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
Primary	Post infusion improvement ratio(PIIR)	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.	pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion
Secondary	To grade clinical outcome using Modified Rankin score	Clinical outcome at 3 months post discharge from hospital after treatment will be evaluated using Modified Rankin score	3 months post discharge from hospital