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

Who is this study for? Adult patients with Cerebral Vasospasm
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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.

Locations
United States
Connecticut
Yale School of Medicine
Terminated
New Haven
Illinois
University of Illinois College of Medicine at Chicago
Withdrawn
Chicago
Michigan
University of Michigan
Withdrawn
Ann Arbor
North Carolina
Wake Forest University Health Sciences
Terminated
Winston-salem
New York
Northwell Health
Recruiting
Manhasset
Lenox Hill
Withdrawn
New York
Pennsylvania
Geisinger Clinic
Recruiting
Danville
Temple University
Withdrawn
Philadelphia
Thomas Jefferson University
Withdrawn
Philadelphia
Texas
University of Texas Medical School at Houston
Recruiting
Houston
Contact Information
Primary
Peng R Chen, MD
Peng.R.Chen@uth.tmc.edu
713-486-8016
Backup
Eddie Aguilar, BA
Eddie.Aguilar@uth.tmc.edu
713-486-7764
Time Frame
Start Date: August 29, 2016
Estimated Completion Date: December 2024
Participants
Target number of participants: 330
Treatments
Active Comparator: Nicardipine
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Active Comparator: Verapamil
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Active Comparator: Nicardipine + Verapamil + Nitroglycerin
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Authors
Nils Petersen, Sunil Sheth, Adnan H Siddiqui, Peng R Chen, Pascal M Jabbour, Ketan R Bulsara, Ali Alaraj, Guiseppe Lanzino
Related Therapeutic Areas
Sponsors
Collaborators: Geisinger Clinic, University of Michigan, Lenox Hill Hospital, Thomas Jefferson University, Yale University, Wake Forest University Health Sciences, University of Illinois at Chicago, Weatherhead, Temple University, Northwell Health
Leads: Peng Roc Chen

This content was sourced from clinicaltrials.gov

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