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Ruptured Aneurysms Treated With Hydrogel Coils

About

Brief Summary

To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.

Study Type
Observational
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
80 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

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Study Stats
Protocol No.
18-000017
Category
Radiological Sciences
Contact
Arineh Aghakhani
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03252314
For detailed technical eligibility, visit ClinicalTrials.gov.