Optima Coil System for Aneurysm (APPLY Trial)

N/A

Waitlist Available

Led By Muhammad A Taqi, MD

Research Sponsored by Vascular Neurology of Southern California Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year during various scheduled visits. specifically, at discharge from hospital, at 3-month follow up and again at 12-months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new coil system called the Balt Optima™ Coil System for treating brain aneurysms. The coils are inserted through a blood vessel in the leg and guided to the brain, where they fill the aneurysm to stop blood flow and prevent it from bursting. The study aims to gather real-world data on how well this system works for patients with both ruptured and unruptured aneurysms.

Eligible Conditions

Aneurysm
Brain Aneurysm
Aorta-Iliac Aneurysms
Cerebral Aneurysm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year during various scheduled visits. specifically, at discharge from hospital, at 3-month follow up and again at 12-months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year during various scheduled visits. specifically, at discharge from hospital, at 3-month follow up and again at 12-months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year during various scheduled visits. specifically, at discharge from hospital, at 3-month follow up and again at 12-months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mortality

Occlusion Rates

Secondary study objectives

Complications

Fluro Time

Modified Rankin Scale (mRS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with Optima Balt CoilsExperimental Treatment1 Intervention

The APPLY study is a single-arm prospective study which means that everyone enrolled in the clinical trial will be/has been treated with the Optima Balt Coils.

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