Ruptured AneurysmRAGENCT03252314
Ruptured Aneurysms Treated With Hydrogel Coils
An observational study of Ruptured Aneurysm, run by Microvention-Terumo, Inc. at 1 site in United States.
Trial summary
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ruptured Aneurysm
- What is being tested?
- Second-generation hydrogel coils
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.
Who may be able to join
- Patient is ≥ 18 and ≤ 80 years of age.
- Patient has a previously untreated, ruptured saccular intracranial aneurysm 2 - 15 mm 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.
- Patient has a baseline Hunt and Hess Score of I, II, or III.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient must be considered by the treating physician to be available for and able to complete all followup visits.
- Patient has not been previously entered into this study.
Who cannot join
- Inability to obtain written informed consent.
- Patient is < 18 or > 80 years of age.
- Patient has a baseline Hunt and Hess score of IV or V.
- Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related.
- Target aneurysm maximum diameter is > 15 mm or < 2 mm.
- Target aneurysm was previously treated via clipping or coiling.
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- Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques.
- Target aneurysm has not been confidently determined by the treating physician to be the source of SAH.
- Planned use of a flow diverter or intrasaccular device as a component of the target aneurysm treatment plan.
- Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless use of a stent is 1) planned as a subsequent stage of a staged coiling procedure or 2) used for bailout purposes.
- Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.
- Patient has a contraindication to heparin or aspirin.
- Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.
- Patient is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician.
- Patient has a serious or life-threatening comorbidity that could confound study results.
- Patient is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.
- Patient is unable to complete scheduled followup assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.
- Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of followup.
- Patient is enrolled in another device or drug study in which participation could confound study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist University Hospital
Memphis, Tennessee, 38120
About this study
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Read the detailed description
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.
- Conditions
- Ruptured Aneurysm
- Being tested
- Second-generation hydrogel coils
- Medical subject headings
- Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-generation hydrogel coilsDevice
Also called HydroFrame, HydroFill, HydroSoft, HydroSoft 3D
Hydrogel coils 90% by length
| Study group | Role | What they receive |
|---|---|---|
| Subjects with ruptured aneurysms | Not described Receives: Device: Second-generation hydrogel coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or major stroke
Measured: 30 days
Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm
Measured: 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
Measured: 18 months
Secondary outcomes (11)
Rebleed rate of the target aneurysm
Measured: 30 days
Rebleed rate of the target aneurysm
Measured: 18 months
Modified Rankin Score (mRS)
Measured: 18 months
Modified Rankin Score (mRS)
Measured: 30 days
Packing density measured by volumetric filling of the aneurysm
Measured: Immediately following procedure
Retreatment rate
Measured: 18 months
Retreatment rate due to recurrence
Measured: 18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm
Measured: 18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm
Measured: 18 months
Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)
Measured: 18 months
Adverse events related to the device and/or the procedure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start27 Nov 2017
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Semmes-Murphey Foundation
- Responsible party
- Sponsor
- Investigators
- Adam S Arthur, MD, MPH, FACS, Principal investigator, Semmes-Murphey ClinicDavid Fiorella, MD, PhD, Principal investigator, Stony Brook Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252314
- Sponsor's protocol ID
- RAGE
- Acronym
- RAGE
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruptured Aneurysms Treated With Hydrogel Coils
- ClinicalTrials.gov ID
- NCT03252314
- Acronym / sponsor ID
- RAGE / RAGE
- Conditions
- Ruptured Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Semmes-Murphey Foundation
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with ruptured aneurysms | – | Device: Second-generation hydrogel coils |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.
Key inclusion criteria (6 listed)
- Patient is ≥ 18 and ≤ 80 years of age.
- Patient has a previously untreated, ruptured saccular intracranial aneurysm 2 - 15 mm 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.
- Patient has a baseline Hunt and Hess Score of I, II, or III.
- Patient or patient's legally authorized representative has provided written informed consent.
- Patient must be considered by the treating physician to be available for and able to complete all followup visits.
Key exclusion criteria (19 listed)
- Inability to obtain written informed consent.
- Patient is < 18 or > 80 years of age.
- Patient has a baseline Hunt and Hess score of IV or V.
- Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related.
- Target aneurysm maximum diameter is > 15 mm or < 2 mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second-generation hydrogel coilsAlso: HydroFrame, HydroFill, HydroSoft, HydroSoft 3DHydrogel coils 90% by length | Device | Subjects with ruptured aneurysms |
Primary outcome
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
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam S Arthur, MD, MPH, FACS principal investigator
Semmes-Murphey Clinic
David Fiorella, MD, PhD principal investigator
Stony Brook Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ruptured Aneurysm, run by Microvention-Terumo, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or major stroke (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.