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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. · Observational

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
03

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.

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 informed consent.
  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 informed consent.
  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 hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.
  12. Patient has a contraindication 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 life expectancy 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.
04

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

05

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

06

Study locations

1 site
  • Methodist University Hospital
    Memphis, Tennessee 38120, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03252314
Lead sponsor
Microvention-Terumo, Inc.
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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