Ruptured Aneurysms Treated With Hydrogel Coils (RAGE)

B
Bradley N. Bohnstedt, MD

Primary Investigator

Enrolling By Invitation
18-80 years
All
Phase N/A
1000 participants needed
1 Location

Brief description of study

To determine safety and occlusion rates when second-generation hydrogel coils are used in theuptured intracranial aneurysms.

Detailed description of study

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 rupturedurysm study population. Secondary objectives include determining clinical outcomes,king density, occlusion stability, rates of recurrence, rebleed, retreatment, and adversevents.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ruptured Aneurysm
  • Age: Between 18 Years - 80 Years
  • Gender: All

Inclusion Criteria:
  1. Patient is ≥ 18 and ≤ 80 years of age.
  2. Patient has a previously untreated, ruptured saccular intracranial aneurysm 2 - 15 mmdiameter for which the clinical decision to treat with hydrogel coil embolizationhas been made independent of the decision to participate in the study described inhis 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.
  5. Patient must be considered by the treating physician to be available for and able towup visits.
  6. Patient has not been previously entered into this study.
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, orAVM-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 orunlikely to be successfully treated by endovascular techniques.
  8. Target aneurysm has not been confidently determined by the treating physician to behe source of SAH.
  9. Planned use of a flow diverter or intrasaccular device as a component of the targeturysm treatment plan.
  10. Intended use of a coil-assist stent as a component of the target aneurysm treatmentunless use of a stent is 1) planned as a subsequent stage of a staged coilingdure or 2) used for bailout purposes.
  11. Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel,y 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 standardby the treating physician.
  15. Patient has a serious or life-threatening comorbidity that could confound studyults.
  16. Patient is at high risk of noncompliance due to a history of substance abuse,ychosocial 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 ofwup.
  19. Patient is enrolled in another device or drug study in which participation couldund study results.

Updated on 01 Aug 2024. Study ID: RAGE
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