Recruiting

Balt Optima™ Coil System

Sponsor:

Vascular Neurology of Southern California Inc.

Code:

NCT04499508

Conditions

Aneurysm

Intracranial Aneurysm

Ruptured Aneurysm

Subarachnoid Hemorrhage, Aneurysmal

Cerebral Aneurysm Unruptured

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Optima Coil System

Study Details

Brief summary:

In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US Food and Drug administration granted Balt USA 510(k) clearance for the Optima Coil System™. Earlier this year, the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils. It consists of coils that come in Standard, Soft and Super Soft profiles and allows for instant detachment from the pusher. The APPLY study is a prospective, single-center investigator-initiated study meant to assess the use of the Balt Optima™ Coil System. The site is looking to enroll approximately 30 subjects over the course of two years. The Optima Coil System™ is commercially available in the United States as such this study is looking for real-world data.

Conditions

Aneurysm

Intracranial Aneurysm

Ruptured Aneurysm

Subarachnoid Hemorrhage, Aneurysmal

Cerebral Aneurysm Unruptured

Study ID

NCT04499508

Start date

Apr 10, 2020

Status verified date

Apr, 2022

Completion date

Apr 9, 2023

Anticipated

Primary completion date

Apr 9, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients age ≥ 18
  • Patients undergoing the embolization of large or small intracranial aneurysms
  • Patient's physician has decided that the best treatment for the patient's neurovascular abnormalities is the Optima Coil System and the patient has agreed to the treatment
  • Of the total number of coils implanted Optima™ Coil System accounts for at least 80%
  • Fully executed IRB approved Informed Consent

Exclusion Criteria:

  • Patient participation in another study that may disrupt the results of this study
  • Anticipated life expectancy of less than 12-months

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with Optima Balt Coils

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.

Interventions

Optima Coil System

Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with

Primary outcome measure

  • Occlusion Rates [ Time Frame: 12 Months ]
  • Mortality [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Anastasia Vechera, BA

805-242-4884avechera@vnsc.org

Muhammad A Taqi, MD

805-242-4884asiftaqi@icloud.com

Locations

Vascular Neurology of Southern California

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Muhammad A Taqi, MD

805-242-4884asiftaqi@icloud.com

Anastasia Vechera, BA

805-242-4884avechera@vnsc.org

Principal Investigator:

Muhammad A Taqi, MD

More Information

Sponsor

Vascular Neurology of Southern California Inc.

Last update posted

Apr 26, 2022

Last verified

Apr, 2022

Keywords

  • Brain aneurysm
  • Optima Coil System
  • Endovascular Coiling
  • Embolization
  • Ruptured Intracranial Aneurysm
  • Unruptured Intracranial Aneurysm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vascular Neurology of Southern California Inc. on 2022-04-26.