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. (part of Terumo Corporation) · 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.
29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 183 across 12 observational studies indexed under Aneurysm, Ruptured.
Browse Aneurysm, Ruptured studies →Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Nov 2017 (actual). Primary completion is estimated for Jun 2025, 91 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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