TARGET Intracranial Aneurysm Coiling Registry
Status unconfirmed
Conditions studied: Intracranial Aneurysms
In brief
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.
Key facts
- Study ID
- NCT01748903
- Run by
- Mercy Health Ohio
- People needed
- 150
- Starts
- 2013-02-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2018-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of Arizona — Phoenix, Arizona, United States (enrolling)
- Tallahassee Neurological Clinic — Tallahassee, Florida, United States (enrolling)
- Presence Saint Joseph Medical Center — Joliet, Illinois, United States (enrolling)
- University of Massachusetts Medical School — Worcester, Massachusetts, United States (enrolling)
- McLaren Health — Flint, Michigan, United States (enrolling)
- SSM DePaul Health Center — St Louis, Missouri, United States (enrolling)
- Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States (enrolling)
- Greenville Health System — Greenville, South Carolina, United States (enrolling)
- West Virginia University Hospital — Morgantown, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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