Ruptured Aneurysms Treated with Hydrogel Coils

Primary Objective

To determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms.

This Study is
No Longer Enrolling

Details
Age

Adult

Eligibility

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.

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.

Type of Study

Observational

Locations

Memorial Hospital Central

Study ID

Protocol Number: 18-6052

More information available at ClinicalTrials.gov: NCT03252314

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