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Trial record 1 of 1 for:    NCT03252314
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Ruptured Aneurysms Treated With Hydrogel Coils (RAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252314
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Semmes-Murphey Foundation
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

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.

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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 : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Tears

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




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 a RROC (Raymond-Roy Occlusion Classification) of 1 or 2 [ 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. Major recurrence rate of the target aneurysm [ Time Frame: 18 months ]
  7. Retreatment rate of the target aneurysm [ Time Frame: 18 months ]
  8. Aneurysm occlusion compared to immediate post-treatment aneurysm occlusion [ Time Frame: 18 months ]
  9. Adverse events related to the device and/or the procedure [ Time Frame: Peri-pocedure ]
  10. Adverse events related to the device and/or the procedure [ Time Frame: Through 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 - 75 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 ≤ 75 years of age.
  2. Patient has a previously untreated, ruptured saccular intracranial aneurysm that is 2 - 14 mm in diameter and is suitable for coil embolization as determined by the treating physician.
  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 > 75 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 > 14mm 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. Intended 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, aspirin, or clopidogrel.
  13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.
  14. Patient unable to undergo DSA or DSA is determined unsuitable 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252314


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

Locations
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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
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Principal Investigator: Adam S Arthur, MD, MPH, FACS Semmes-Murphey Clinic
Principal Investigator: David Fiorella, MD, PhD Stony Brook Medical Center
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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03252314    
Other Study ID Numbers: RAGE
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aneurysm
Aneurysm, Ruptured
Rupture
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries