Ruptured Aneurysms Treated With Hydrogel Coils

NCT ID: NCT03252314

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2025-12-31

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 population. Secondary objectives include determining clinical outcomes, packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse events.

Conditions

Ruptured Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with ruptured aneurysms

Second-generation hydrogel coils

Intervention Type: DEVICE

Hydrogel coils 90% by length

Interventions

Second-generation hydrogel coils

Hydrogel coils 90% by length

Intervention Type: DEVICE

Other Intervention Names

HydroFrame; HydroFill; HydroSoft; HydroSoft 3D

Eligibility Criteria

Inclusion Criteria

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 this protocol.

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 > 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 AVM-related.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmes-Murphey Foundation

OTHER

Sponsor Role: collaborator

Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam S Arthur, MD, MPH, FACS

Role: PRINCIPAL_INVESTIGATOR

Semmes-Murphey Clinic

David Fiorella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medical Center

Locations

Methodist University Hospital

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

RAGE

Identifier Type: -

Identifier Source: org_study_id