Intra-arterial Drug Therapy for Cerebral Vasospasm
(iVAST Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPeng R Chen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Peng Roc Chen

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-80 who've had a ruptured aneurysm treated and then developed cerebral vasospasm within 3-21 days post-surgery. It's not for those unable to consent, pregnant women, outside the age range, with severe subarachnoid hemorrhage (Hunt Hess Grade 5), or have already received treatment in all arterial territories.

Inclusion Criteria

My angiogram showed more than 50% narrowing after aneurysm treatment.

I am 18-80 years old and had a brain aneurysm rupture, with complications within 3-21 days after surgery.

I have symptoms of narrowed blood vessels in my brain.

Exclusion Criteria

I have received drug treatment through an artery in all 3 arterial territories.

Inability to obtain consent from patient or patients kin

Pregnant women

See 2 more

Treatment Details

Interventions

Nicardipine (Calcium Channel Blocker)
Nicardipine + Verapamil + Nitroglycerin (Calcium Channel Blocker + Nitrate)
Verapamil (Calcium Channel Blocker)

Trial OverviewThe study aims to find the best intra-arterial drug combo for restoring blood vessel width after cerebral vasospasm due to aneurysmal subarachnoid hemorrhage. It compares Nicardipine, Verapamil, and their combination with Nitroglycerin on artery opening and patient recovery at 90 days.

Participant Groups

3Treatment groups

Active Control

Group I: VerapamilActive Control1 Intervention

Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty

Group II: NicardipineActive Control1 Intervention

Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty

Group III: Nicardipine + Verapamil + NitroglycerinActive Control1 Intervention

Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty