Status:
ACTIVE_NOT_RECRUITING
Ruptured Aneurysms Treated With Hydrogel Coils
Lead Sponsor:
Microvention-Terumo, Inc.
Collaborating Sponsors:
Semmes-Murphey Foundation
Conditions:
Ruptured Aneurysm
Eligibility:
All Genders
18-80 years
Brief Summary
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Detailed 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 populatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03252314
Start Date
November 27 2017
End Date
December 1 2025
Last Update
July 23 2024
Active Locations (1)
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1
Methodist University Hospital
Memphis, Tennessee, United States, 38120