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Coil System

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

APPLY Trial Summary

This trial is studying a new type of detachable coil for the treatment of intracranial aneurysms.

Eligible Conditions

Aneurysm
Brain Aneurysm
Cerebral Aneurysm

APPLY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mortality

Occlusion Rates

Secondary outcome measures

Complications

Fluro Time

Modified Rankin Scale (mRS)

+5 more

APPLY 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vascular Neurology of Southern California Inc.Lead Sponsor

Anastasia Vechera, BAStudy DirectorVascular Neurology of Southern California

Muhammad A Taqi, MDPrincipal InvestigatorVascular Neurology of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being tracked in this research study?

"Affirmative. Clinicaltrials.gov reveals that this trial, initially posted on April 10th 2020, is still recruiting participants. The researchers are seeking thirty volunteers from a single medical centre."

Answered by AI

Are there still vacancies available for this research project?

"According to clinicaltrials.gov, the recruitment of patients for this research is currently underway. Researchers initially posted the study on April 10th 2020 and made their latest alterations 25 months later in April 2022."

Answered by AI

What is the underlying purpose of this research endeavor?

"Monitoring the Occlusion Rates over a 12-month period will serve as the primary outcome for this study. Secondary objectives include examining Raymond-Roy Occlusion classification, Serious Adverse Events post-procedure at discharge, 3 months, and after the final visit, and Fluro Time per patient case. Class I indicates complete obliteration of aneurysm while class II shows residual neck is left after coiling. Class IIIa may improve to either class I or II with time whereas class IIIb has wider larger remainders with higher retreatment rates. Preferably outcomes should be classified as class I or II ("

Answered by AI

Recent research and studies

Interventional NeuroradiologyJournal

History of Endovascular Endosaccular Occlusion of Brain Aneurysms: 1965–1990

Guglielmi, G.. 2007. “History of Endovascular Endosaccular Occlusion of Brain Aneurysms: 1965–1990”. Interventional Neuroradiology. SAGE Publications. doi:10.1177/159101990701300301.

Journal of NeuroInterventional SurgeryJournal

An Update to the Raymond–roy Occlusion Classification of Intracranial Aneurysms Treated with Coil Embolization

Mascitelli, Justin R, Henry Moyle, Eric K Oermann, Maritsa F Polykarpou, Aanand A Patel, Amish H Doshi, Yakov Gologorsky, Joshua B Bederson, and Aman B Patel. 2014. “An Update to the Raymond–roy Occlusion Classification of Intracranial Aneurysms Treated with Coil Embolization”. Journal of Neurointerventional Surgery. BMJ. doi:10.1136/neurintsurg-2014-011258.

Journal of NeurosurgeryJournal

Surgical Risk as Related to Time of Intervention in the Repair of Intracranial Aneurysms

Hunt, William E., and Robert M. Hess. 1968. “Surgical Risk as Related to Time of Intervention in the Repair of Intracranial Aneurysms”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/jns.1968.28.1.0014.

Journal of NeurosurgeryJournal