Clinical trial NCT03252314: Ruptured Aneurysms Treated With Hydrogel Coils
Official title: Ruptured Aneurysms Treated With Hydrogel Coils
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ruptured Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Semmes-Murphey Foundation
First posted: 2017-08-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Death or major stroke
timeFrame: 30 days
measure: Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm
timeFrame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm
timeFrame: 18 months
Secondary outcomes:
measure: Rebleed rate of the target aneurysm
timeFrame: 30 days
measure: Rebleed rate of the target aneurysm
timeFrame: 18 months
measure: Modified Rankin Score (mRS)
timeFrame: 18 months
measure: Modified Rankin Score (mRS)
timeFrame: 30 days
measure: Packing density measured by volumetric filling of the aneurysm
timeFrame: Immediately following procedure
measure: Retreatment rate
timeFrame: 18 months
measure: Retreatment rate due to recurrence
timeFrame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm
timeFrame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm
timeFrame: 18 months
measure: Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)
timeFrame: 18 months
measure: Adverse events related to the device and/or the procedure
timeFrame: 18 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
Study officials:
affiliation: Semmes-Murphey Clinic
name: Adam S Arthur, MD, MPH, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook Medical Center
name: David Fiorella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: