Ruptured Aneurysms Treated With Hydrogel Coils (RAGE)

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

Study Overview

• Status: Recruiting
• Conditions: Ruptured Aneurysm
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Kellee Rivera, Semmes Murphey Foundation; Phone Number: 901-260-6111; Email: krrivera@semmes-murphey.com

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Methodist University Hospital
      • Contact: Amanda Nolte; Phone Number: 901-259-5316; Email: annolte@semmes-murphey.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Rebleed rate of the target aneurysm	30 days
Rebleed rate of the target aneurysm	18 months
Modified Rankin Score (mRS)	18 months
Modified Rankin Score (mRS)	30 days
Packing density measured by volumetric filling of the aneurysm	Immediately following procedure
Retreatment rate	18 months
Retreatment rate due to recurrence	18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm	18 months
Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm	18 months
Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)	18 months
Adverse events related to the device and/or the procedure	18 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Ruptured
• Other Study ID Numbers: RAGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes