Ruptured Aneurysms Treated With Hydrogel Coils

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    1000
  • sponsor
    Microvention-Terumo, Inc.
Updated on 30 January 2021

Summary

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

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.

Details
Condition Ruptured aneurysm, Aneurysm, Aneurysm, ruptured aneurysms
Treatment Second-generation hydrogel coils
Clinical Study IdentifierNCT03252314
SponsorMicrovention-Terumo, Inc.
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

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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