An observational study in Ruptured Aneurysm, sponsored by Microvention-Terumo, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Microvention-Terumo, Inc. · Observational
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is designed to determine the safety and occlusion rates of hydrogel coils in the ruptured aneurysm study population. Secondary objectives include determining clinical outcomes, packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse events.
Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.
Exclusion Criteria:
Device: Second-generation hydrogel coils
Hydrogel coils 90% by length
Also known as: HydroFrame, HydroFill, HydroSoft, HydroSoft 3D
Death or major stroke
Time frame: 30 days
Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm
Time frame: 18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm
Time frame: 18 months
Rebleed rate of the target aneurysm
Time frame: 30 days
Rebleed rate of the target aneurysm
Time frame: 18 months
Modified Rankin Score (mRS)
Time frame: 18 months
Modified Rankin Score (mRS)
Time frame: 30 days
Packing density measured by volumetric filling of the aneurysm
Time frame: Immediately following procedure
Retreatment rate
Time frame: 18 months
Retreatment rate due to recurrence
Time frame: 18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm
Time frame: 18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm
Time frame: 18 months
Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)
Time frame: 18 months
Adverse events related to the device and/or the procedure
Time frame: 18 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Microvention-Terumo, Inc.