Ruptured Aneurysms Treated With Hydrogel Coils (RAGE)

• ClinicalTrials.gov Identifier: NCT03252314
• Recruitment Status: Recruiting
• First Posted: August 17, 2017
• Last Update Posted: March 10, 2022
• Sponsor: Microvention-Terumo, Inc.
• Collaborator: Semmes-Murphey Foundation
• Information provided by (Responsible Party): Microvention-Terumo, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Ruptured Aneurysm	Device: Second-generation hydrogel coils

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ruptured Aneurysms Treated With Hydrogel Coils
• Actual Study Start Date: November 27, 2017
• Estimated Primary Completion Date: June 2025
• Estimated Study Completion Date: December 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
Subjects with ruptured aneurysms	Device: Second-generation hydrogel coils; Hydrogel coils 90% by length; Other Names: HydroFrame; HydroFill; HydroSoft; HydroSoft 3D

Outcome Measures

Primary Outcome Measures :

1. Death or major stroke [ Time Frame: 30 days ]
2. Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm [ Time Frame: 18 months ]
3. Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. Rebleed rate of the target aneurysm [ Time Frame: 30 days ]
2. Rebleed rate of the target aneurysm [ Time Frame: 18 months ]
3. Modified Rankin Score (mRS) [ Time Frame: 18 months ]
4. Modified Rankin Score (mRS) [ Time Frame: 30 days ]
5. Packing density measured by volumetric filling of the aneurysm [ Time Frame: Immediately following procedure ]
6. Retreatment rate [ Time Frame: 18 months ]
7. Retreatment rate due to recurrence [ Time Frame: 18 months ]
8. Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm [ Time Frame: 18 months ]
9. Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm [ Time Frame: 18 months ]
10. Occlusion Stability (as defined by the Raymond Roy Occlusion Classification) [ Time Frame: 18 months ]
11. Adverse events related to the device and/or the procedure [ Time Frame: 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.

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.

Contacts and Locations

Contacts

Contact: Kellee Rivera, Semmes Murphey Foundation; 901-260-6111; krrivera@semmes-murphey.com

Locations

United States, Tennessee

Methodist University Hospital; Recruiting

Memphis, Tennessee, United States, 38120

Contact: Amanda Nolte 901-259-5316 annolte@semmes-murphey.com

Sponsors and Collaborators

Microvention-Terumo, Inc.

Semmes-Murphey Foundation

Investigators

• Principal Investigator: Adam S Arthur, MD, MPH, FACS; Semmes-Murphey Clinic
• Principal Investigator: David Fiorella, MD, PhD; Stony Brook Medical Center

More Information

• Responsible Party: Microvention-Terumo, Inc.
• ClinicalTrials.gov Identifier: NCT03252314
• Other Study ID Numbers: RAGE
• First Posted: August 17, 2017
• Last Update Posted: March 10, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Aneurysm; Aneurysm, Ruptured; Vascular Diseases; Cardiovascular Diseases