TARGET Intracranial Aneurysm Coiling Registry

Mercy Health Ohio

Status: Unknown

Conditions: Intracranial Aneurysms

Treatments: Device: Target 360°, 2D Coils, Nano Coils

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01748903

19180

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

150 participants in 1 patient group

Target 360°, 2D, Nano Coils

Description:

Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.

Treatment:

Device: Target 360°, 2D Coils, Nano Coils