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

April 25, 2022 updated by: Vascular Neurology of Southern California Inc.

APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intracranial aneurysms both ruptured and unruptured collectively affect a significant portion of the general population. Cases of unruptured intracranial aneurysms (UIA) are estimated to affect roughly 3% of the general population and aneurysmal subarachnoid hemorrhage (aSAH) has an incidence of 8 to 9 people per 100,000. There are two well-established treatment options for patients diagnosed with intracranial aneurysms (IA): surgical clipping and endovascular coiling. Neurosurgical intervention requires a craniotomy followed by the clipping of the aneurysm. Endovascular repair is minimally invasive as access to the afflicted vessel is gained through the femoral artery with the assistance of imaging guidance. During embolization, the aneurysm is occluded using coils of varying length, diameter, and softness. By filling the dome of the aneurysm physicians aim to prevent further blood flow into the bulge which will prevent the aneurysm from rupturing. In addition to coiling a stent may be placed to function as a blood flow diverting device.

The first-ever recorded use of coils in the treatment of intracranial aneurysms by way of endovascular intervention was in 1988. In 1989, detachable coils were designed by Guido Guglielmi, an endovascular neurosurgeon, who pioneered the concept of coil embolization. Since then, endovascular embolization has become effective, and in some cases preferred, method of treatment of intracranial aneurysms. A 2005 randomized, multicenter study titled International Subarachnoid Aneurysm Trial (ISAT) demonstrated that in comparison to surgical clipping, endovascular repair clinical outcomes result in significant risk reduction and long-term independence post-procedure. To verify their findings the ISAT authors reviewed the clinical outcomes at 1 year of 1063 of 1072 patients who underwent ruptured aneurysm embolization using detachable coils compared to 1055 of 1070 who were designated to neurosurgical clipping. At the one-year mark patients who experienced endovascular repair demonstrated poor prognosis with less frequency, as measured by mortality and extent of dependency, in 23.5% of cases in comparison to 30.9% of subjects treated via neurosurgical intervention. While the results seem to show a considerable preference for embolization, the patients in this designated sample were found to experience rebleeds at a higher frequency. Beyond resurgence of hemorrhaging, embolization risks include aneurysm perforation and/or rupture, thromboembolic events, and coil herniation out of the occluded site. Despite the aforementioned risk factors, it has become clear that embolization with detachable coils is a much safer treatment option as the rate of procedure-related complications is relatively low. This is true for patients with unruptured and ruptured intracranial aneurysms-size and location did not show any statistically significant impact.

The study will enroll approximately 30 subjects to allow us to adequately observe the benefits of the central limit theorem. Based on prior experience, we expect that approximately 10% of all participants may be lost to follow-up and/or will withdraw from the study. It is estimated that two years are needed to complete the study. The first year will be necessary to enroll 30 subjects and the second year will be necessary to complete the 12-month follow-up visits and study close out procedures. The device is to be used per Instructions for Use as indicated for treatment of intracranial aneurysms by way of coil embolization. Participating in this study will not contribute or be of detriment in any way of a subject's medical care. All study related data gathering activities are standard of care and do not require any special actions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Vascular Neurology of Southern California
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad A Taqi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Optima Coil System
Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with
Other Names:
  • Embolization of Intracranial Aneurysm
  • Optima Balt Coil System
  • Neurovascular Embolization Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occlusion Rates
Time Frame: 12 Months
Successful occlusion rates defined as Raymond-Roy Occlusion Class I and II.
12 Months
Mortality
Time Frame: 12 Months
All-cause mortality.
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occlusion Scale Score
Time Frame: Immediately post-procedure, 3-Months, and 12-Months
Raymond-Roy Occlusion classification is measured via angiographic imaging of endovascularly treated intracranial aneurysms. The classes are the following: Class I indicates complete obliteration of the aneurysm. Class II indicates that post-coiling some residual neck is left. Class IIIa indicates residual aneurysm remains after coiling but these are likely to improve to Class I or II over time. Class IIIb indicates residual aneurysm remains but these are wider and larger, they also have a higher retreatment rate. Ideal aneurysm coiling classification post procedure is Class I, Class II, and in some cases Class IIIa.
Immediately post-procedure, 3-Months, and 12-Months
Modified Rankin Scale (mRS)
Time Frame: Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months.
Good Clinical Outcome defined as mRS = 0 - 2. The modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disability via interview of subject or family. The scale ranges from 0 to 6, with 0 being the best outcome and 6 being the worst. Score 0 = patient shows no symptoms. Score 1 = no significant disability despite some symptoms, but patient is able to carry out all usual duties/activities. Score 2 = slight disability, patient is unable to carry out all previous activities but is able to look after their own affairs. Score 3 = moderate disability, requiring some help, but able to walk without assistance. Score 4 = moderate severe disability, patient is unable to walk and/or attend to their own bodily needs. Score 5 = severe disability, patient is bedridden, incontinent and requires constant nursing care. Score 6 = patient has expired.
Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months.
Packing Density
Time Frame: Result is known immediately post-procedure.
Number of coils necessary for packing density
Result is known immediately post-procedure.
Fluro Time
Time Frame: Result is known immediately post-procedure.
Fluro time per case.
Result is known immediately post-procedure.
Other Devices Used
Time Frame: Result is known immediately post-procedure.
Use of adjuncts, stent/balloon/Comaneci
Result is known immediately post-procedure.
Complications
Time Frame: At all time points from procedure to 12 Months.
Major complications (i.e. intraoperative complications: inadvertent coil detachment, rupture/re-rupture, retreatment)
At all time points from procedure to 12 Months.
SAE
Time Frame: At all time points from procedure to 12 Months.
Serious Adverse Events post-procedure at discharge, 3-months, and through the final 12-month visit-device related or otherwise.
At all time points from procedure to 12 Months.
Thromboembolic Events
Time Frame: At all time points from procedure to 12 Months.
Post-treatment major thromboembolic events are defined as stroke events that occur immediately after the index procedure. Post endovascular coiling subjects are often at risk for stroke, this occurs as a formation in the blood vessel of a clot breaks loose and is carried by the blood stream and occludes another vessel. Thromboembolic events represent one of the most serious complications of embolization therapy, due to the possibility of permanent neurologic disability and death. As such these events will be closely monitored. This is not a quantitative or qualitative measurement but rather an archive of the circumstances should an event occur.
At all time points from procedure to 12 Months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascular Neurology of Southern California Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad A Taqi, MD, Vascular Neurology of Southern California
  • Study Director: Anastasia Vechera, BA, Vascular Neurology of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VNSC-022020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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