The Intra-arterial Vasospasm 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.

Conditions

• Cerebral Vasospasm

Interventions

DRUG

Nicardipine

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

DRUG

Verapamil

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

DRUG

Nicardipine + Verapamil + Nitroglycerin

Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Temple University

  collaborator OTHER

• Geisinger Clinic

  collaborator OTHER

• Northwell Health

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Lenox Hill Hospital

  collaborator OTHER

• Weatherhead Foundation

  collaborator UNKNOWN

• University of California, Irvine

  collaborator OTHER

• Peng Roc Chen, MD

  lead OTHER

Principal Investigators

• Peng R Chen, MD · University of Texas Medical School at Houston

• Ketan R Bulsara, MD, MBA · UConn Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-29

Primary Completion

2024-04-29

Completion

2024-08-12

Countries

• United States

Study Locations