Trial Search Results
Ruptured Aneurysms Treated With Hydrogel Coils
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Stanford is currently accepting patients for this trial.
Collaborator: Semmes-Murphey Foundation
- Device: Second-generation hydrogel coils
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
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 to
complete all followup visits.
6. Patient has not been previously entered into this study.
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
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
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
19. Patient is enrolled in another device or drug study in which participation could
confound study results.
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study