Ruptured Aneurysms Treated With Hydrogel Coils

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.

Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 75 years of age.

2. Patient has a previously untreated, ruptured saccular intracranial aneurysm that is 2
- 14 mm in diameter and is suitable for coil embolization as determined by the
treating physician.

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:

1. Inability to obtain written informed consent.

2. Patient is < 18 or > 75 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 > 14mm 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. Intended 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, aspirin, or clopidogrel.

13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.

14. Patient unable to undergo DSA or DSA is determined unsuitable 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.