NCT01996436

The Intra-arterial Vasospasm Trial

The Intra-arterial Vasospasm Trial - A Multi-center Randomized Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Peng Roc Chen, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. This study is a prospective multicenter randomized trial. The primary outcome measure is the Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post intra-arterial drug infusion in the presenting vasospasmic blood vessel. Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a secondary outcome to assess clinical outcome. The interventions in this study are a part of routine standard of care (SOC) procedures for cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal medical management, endovascular treatment by intra-arterial drug infusion of single drug agent or cocktail drug agents will be initiated. Study participants will be randomly assigned to one of the three treatment groups where one single drug agent or cocktail drug agents will be intra-arterially administered. Pre \& post infusion vasospasmic vessel diameters will be compared. The change in diameter will be quantified based on the mean percentage change. Three months post hospital discharge, study participants will be followed up in clinic to evaluate clinical outcome. The study will require 330 patients in total. The patient population will be hospitalized patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage. Subjects will be stratified by randomization into 3 treatment groups.

Conditions

• Cerebral Vasospasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-29
• Primary completion: 2024-04-29
• Completion: 2024-08-12
• First posted: 2013-11-27
• Last updated: 2025-05-11
• Results posted: 2025-05-11

Locations

5 sites across 1 country: United States