The Intra-arterial Vasospasm Trial

Stopped early · Phase 4

Conditions studied: Cerebral Vasospasm

In brief

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.

Key facts

Study ID

NCT01996436

Run by

Peng Roc Chen, MD

People needed

92

Starts

2016-08-29

Expected to finish

2024-08-12

Last updated by the study team

2025-05-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States
• Northwell Health — Manhasset, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Geisinger Clinic — Danville, Pennsylvania, United States
• University of Texas Medical School at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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