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TARGET Intracranial Aneurysm Coiling Registry | Clinical Trials | Clareo Health

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TARGET Intracranial Aneurysm Coiling Registry

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

NCT01748903•Mercy Health Ohio

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (9)

University of Arizona

Phoenix, Arizona, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Presence Saint Joseph Medical Center

Joliet, Illinois, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

McLaren Health

Flint, Michigan, United States

SSM DePaul Health Center

St Louis, Missouri, United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Greenville Health System

Greenville, South Carolina, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

January 1, 2019

Completion Date

March 1, 2019

Last Updated

July 24, 2018

Enrollment

150

ESTIMATED participants

Conditions

Intracranial Aneurysms

Interventions

Target 360°, 2D Coils, Nano Coils

DEVICE

Contacts

Victoria J Calderon, MPH

CONTACT

4192514367 vcalderon@mercy.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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