To determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
All eligible subjects presenting to any participating study site will be considered for enrollment. Up to 1000 patients; 18 and ; 75 years presenting with ruptured saccular aneurysms who meet all eligibility criteria will be enrolled.
Detailed Eligibility: 1. Subject is ≥ 18 and ≤ 75 years of age. 2. Subject has a previously untreated, ruptured saccular intracranial aneurysm 2- 14mm in diameter for which the clinical decision to treat with hydrogel coil embolization has been made independent of the decision to participate in the study described in this protocol. 3. Subject has a baseline Hunt and Hess Score of I, II, or III. 4. Subject or subject’s legally authorized representative has provided written informed consent. 5. Subject must be considered by the treating physician to be available for and able to complete all followup visits. 6. Subject has not been previously entered into this study.
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Memorial Hospital Central
Protocol Number: 18-6052
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