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Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)

NCT04499508 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-26

No results posted yet for this study

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

Interventions

DEVICE

Optima Coil System

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

Sponsors & Collaborators

  • Vascular Neurology of Southern California Inc.

    lead INDUSTRY

Principal Investigators

  • Muhammad A Taqi, MD · Vascular Neurology of Southern California

  • Anastasia Vechera, BA · Vascular Neurology of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2023-04-09
Completion
2023-04-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04499508 on ClinicalTrials.gov