TerminatedPhase 4

The Intra-arterial Vasospasm Trial

Stopped: Slow enrollment

United States92 participantsStarted 2016-08-29

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Post Infusion Improvement Ratio (PIIR)

Timeframe: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion

Trial details

NCT IDNCT01996436

SponsorPeng Roc Chen, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-29

Results submitted2025-04-29