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Title The Intra-arterial Vasospasm Trial - A Multicenter Randomized Study
Therapeutic Area Aneurysms, Subarachnoid Hemorrhage
Principal Investigator Adel Malek, MD, PhD
Min Age 18 Years
Max Age 80 Years
Gender Any
Contact Pradnya Ghule and Leidy Guzman
617-636-7606 and 617-636-7620
More Information


The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.

Study Details

Inclusion Criteria

  • Adult patients with ruptured aneurysms requiring surgery or endovascular therapy and who experience vasospasm post-operatively (3-21 days post-procedure)
  • 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

  • Pregnant women (confirmed by a positive pregnancy test)
  • Hunt Hess (HH) grade 5
  • Intra-arterial drug treatment in all 3 arterial territories

Study Requirements

The total duration for study participation required is the standard hospital stay for postaSAH vasospasm treatment and one follow-up clinic visit at 3 months following hospital discharge. For this clinical trial no additional clinical or laboratory evaluations are required apart from the standard hospital routine care procedures. The total study time frame is 24 months (18 months for enrollment + 3 months follow up and ± 3 months to accommodate any scheduling conflict and data gathering).