TARGET Intracranial Aneurysm Coiling Registry

Last updated: July 20, 2018
Sponsor: Mercy Health Ohio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

N/A

Clinical Study ID

NCT01748903
19180
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 informedconsent.

  7. Patient is willing to and can comply with study follow-up requirements.

Exclusion

Exclusion Criteria:

  1. Patient is < 18 years old.

  2. Dissecting aneurysm.

  3. Patients with intracranial aneurysms (other than the target aneurysm) that willrequire treatment during the study period (enrollment through follow-up).

  4. Patients in whom the target aneurysm will be treated with coils other than StrykerTarget® 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 coillength 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. stagedprocedure)

Study Design

Total Participants: 150
Study Start date:
February 01, 2013
Estimated Completion Date:
March 31, 2019

Connect with a study center

  • University of Arizona

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Desert Regional Medical Center

    Palm Springs, California 92264
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Presence Saint Joseph Medical Center

    Joliet, Illinois 60435
    United States

    Active - Recruiting

  • University of Massachusetts Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Michigan State University

    East lansing, Michigan 48824
    United States

    Site Not Available

  • McLaren Health

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • SSM DePaul Health Center

    Saint Louis, Missouri 63132
    United States

    Active - Recruiting

  • SSM DePaul Health Center

    St. Louis, Missouri 63132
    United States

    Site Not Available

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio 43604
    United States

    Active - Recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Greenville Health System

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Texas Stroke Institute

    Plano, Texas 75075
    United States

    Site Not Available

  • West Virginia University Hospital

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

  • Gundersen Lutheran

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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