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Active, not recruitingNCT03252314RAGEUpdated Jul 23, 2024

Ruptured Aneurysms Treated With Hydrogel Coils

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

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ruptured Aneurysm

Browse trials for

03

In context

Aneurysm, Ruptured

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  1. Patient is ≥ 18 and ≤ 80 years of age.
  2. 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.
  3. Patient has a baseline Hunt and Hess Score of I, II, or III.
  4. Patient or patient's legally authorized representative has provided written .
  5. Patient must be considered by the treating physician to be available for and able to complete all followup visits.
  6. Patient has not been previously entered into this study.

Exclusion criteria

Exclusion Criteria:

  1. Inability to obtain written .
  2. Patient is \< 18 or > 80 years of age.
  3. Patient has a baseline Hunt and Hess score of IV or V.
  4. Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related.
  5. Target aneurysm maximum diameter is > 15 mm or \< 2 mm.
  6. Target aneurysm was previously treated via clipping or coiling.
  7. Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques.
  8. Target aneurysm has not been confidently determined by the treating physician to be the source of SAH.
  9. Planned use of a flow diverter or intrasaccular device as a component of the target aneurysm treatment plan.
  10. 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.
  11. Patient has a known, untreatable to contrast dye, iodine, hydrogel, or any other component of the treatment device.
  12. Patient has a to heparin or aspirin.
  13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.
  14. Patient is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician.
  15. Patient has a serious or life-threatening comorbidity that could confound study results.
  16. Patient is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.
  17. Patient is unable to complete scheduled followup assessments due to comorbidities, geographical limitations, or a of less than 18 months.
  18. Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of followup.
  19. Patient is enrolled in another device or drug study in which participation could confound study results.
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Subjects with ruptured aneurysms

    Device: Second-generation hydrogel coils

Interventions

  • DeviceSecond-generation hydrogel coils

    Hydrogel coils 90% by length

    Also known as: HydroFrame, HydroFill, HydroSoft, HydroSoft 3D

06

What researchers measure

Primary outcomes

  1. Death or major stroke

    Time frame: 30 days

  2. Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm

    Time frame: 18 months

  3. 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

Secondary outcomes

  1. Rebleed rate of the target aneurysm

    Time frame: 30 days

  2. Rebleed rate of the target aneurysm

    Time frame: 18 months

  3. Modified Rankin Score (mRS)

    Time frame: 18 months

  4. Modified Rankin Score (mRS)

    Time frame: 30 days

  5. Packing density measured by volumetric filling of the aneurysm

    Time frame: Immediately following procedure

  6. Retreatment rate

    Time frame: 18 months

  7. Retreatment rate due to recurrence

    Time frame: 18 months

  8. Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm

    Time frame: 18 months

  9. 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

  10. Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)

    Time frame: 18 months

  11. Adverse events related to the device and/or the procedure

    Time frame: 18 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Aug 9, 2017
First posted
Aug 17, 2017
StartActual
Nov 27, 2017
Primary completionEst.
Jun 2025
CompletionEst.
Dec 2025
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03252314
Collaborators
Semmes-Murphey Foundation
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Nov 27, 2017
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jul 23, 2024

Study contacts

Adam S Arthur, MD, MPH, FACS
principal investigator · Semmes-Murphey Clinic
David Fiorella, MD, PhD
principal investigator · Stony Brook Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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