Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT01748903
Status
Recruiting
Sponsor
Mercy Health Ohio

Study Contact

Victoria J Calderon, MPH
4192514367
vcalderon@mercy.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.