TARGET Intracranial Aneurysm Coiling Registry (TARGET)

July 20, 2018 updated by: Dr. Osama O. Zaidat, Mercy Health Ohio

TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd Generation Target® Nano Coils

The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.

Study Overview

Status

Status

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

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.

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.
Observational

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.
150

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 Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • University of Arizona
        • Principal Investigator:
          • Peter J Sunenshine, MD
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Neurological Clinic
        • Principal Investigator:
          • Matthew Lawson, MD
        • Sub-Investigator:
          • Narlin Beaty, MD
        • Principal Investigator:
          • T. Adam Oliver, MD
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Recruiting
        • Presence Saint Joseph Medical Center
        • Principal Investigator:
          • Aamir Badruddin, MD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Medical School
    • Michigan
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Health
        • Principal Investigator:
          • Aniel Q Majjhoo, MD
        • Sub-Investigator:
          • Bharath R Naravetla, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63132
        • Recruiting
        • SSM DePaul Health Center
        • Principal Investigator:
          • Amer Alshekhlee, MD
        • Sub-Investigator:
          • Richard Callison, MD
    • Ohio
      • Toledo, Ohio, United States, 43604
        • Recruiting
        • Mercy Health St. Vincent Medical Center
        • Principal Investigator:
          • Osama O Zaidat, MD, MS
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Greenville Health System
        • Principal Investigator:
          • Mahmoud Rayes, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • West Virginia University Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All sequential patients presenting with unruptured and ruptured saccular aneurysms, who meet all eligibility criteria, will be considered for study enrollment.

Description

Inclusion Criteria:

  1. Patient is 18 years or older.
  2. Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
  3. (NEW NANO arm ONLY) Target aneurysm is ≤7mm.
  4. Patient has a Hunt and Hess Score of 3 or less.
  5. Patient has a premorbid mRS of 3 or less.
  6. Patient or patient's legally authorized representative has provided written informed consent.
  7. Patient is willing to and can comply with study follow-up requirements.

Exclusion Criteria:

  1. Patient is < 18 years old.
  2. Dissecting aneurysm.
  3. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
  4. Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.
  5. (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of <25% Stryker Target® 2nd generation Nano Coils.
  6. Target aneurysm is fusiform.
  7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Target 360°, 2D, Nano Coils
Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.
Device: Target 360°, 2D Coils, Nano Coils
Other Names:
  • Target coils
  • Target Nano coil

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
Packing Density
Time Frame: At immediate post-procedure (Day 1)
Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.
At immediate post-procedure (Day 1)

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 Rate
Time Frame: At immediate post-procedure (Day 1) and 3-9 month follow-up
Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.
At immediate post-procedure (Day 1) and 3-9 month follow-up
Aneurysm Re-access Rate
Time Frame: At end of study procedure (Day 1)
The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.
At end of study procedure (Day 1)
Time of Fluoroscopic Exposure
Time Frame: At immediate post-procedure (Day 1)
Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.
At immediate post-procedure (Day 1)
Overall Procedure Time
Time Frame: At Immediate post-procedure (Day 1)
The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.
At Immediate post-procedure (Day 1)
Aneurysm Recurrence
Time Frame: 3-9 month follow-up
3-9 month follow-up
Aneurysm Re-treatment Rate
Time Frame: 3-9 month follow-up
Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up
3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate
Time Frame: 3-9 month follow-up
Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
3-9 month follow-up
Treatment-related Morbidity and Mortality
Time Frame: from study procedure (Day 1) to 3-9 month follow-up
Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.
from study procedure (Day 1) to 3-9 month follow-up
Modified Rankin Score
Time Frame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.
At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
Device-related serious adverse events
Time Frame: From the study procedure (Day 1) until 3-9 month follow up
Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.
From the study procedure (Day 1) until 3-9 month follow up
Length of hospital stay
Time Frame: At hospital discharge (Day 3)
Length of hospital stay will be recorded at the time of patient discharge.
At hospital discharge (Day 3)
Technical and clinical endpoints of Target 360° and 2D coils
Time Frame: 3-9 month follow-up
A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.
3-9 month follow-up

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.
Mercy Health Ohio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Neurovascular

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: Osama O Zaidat, MD, MS, Mercy Health St. Vincent Medical Center

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

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.
February 1, 2013

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.
January 1, 2019

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.
March 1, 2019

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).
December 7, 2012

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.
December 12, 2012

First Posted (Estimate)

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.
December 13, 2012

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.
July 24, 2018

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.
July 20, 2018

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.
July 1, 2018

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.
  • 19180

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings