TARGET Intracranial Aneurysm Coiling Registry
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.
- Intracranial Aneurysms
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Patient is 18 years or older.
- Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
- (NEW NANO arm ONLY) Target aneurysm is ≤7mm.
- Patient has a Hunt and Hess Score of 3 or less.
- Patient has a premorbid mRS of 3 or less.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient is willing to and can comply with study follow-up requirements.
- Patient is < 18 years old.
- Dissecting aneurysm.
- Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
- 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.
- (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.
- Target aneurysm is fusiform.
- Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
- Study Type
- Observational [Patient Registry]
- Observational Model
- Time Perspective
|Target 360°, 2D, Nano Coils||Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.||
- Mercy Health Ohio
Study ContactVictoria J Calderon, MPH