TARGET Intracranial Aneurysm Coiling Registry
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
- Intracranial Aneurysms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned Intervention |
---|---|---|
Target 360°, 2D, Nano Coils | Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm. |
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Recruiting Locations
More Details
- Status
- Unknown status
- Sponsor
- Mercy Health Ohio