Ruptured Aneurysms Treated With Hydrogel Coils

NCT03252314 | Active Not Recruiting FDA Device

• 1 other identifier: RAGE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ruptured Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (1)

Subjects with ruptured aneurysms

Device: Second-generation hydrogel coils

Interventions

Second-generation hydrogel coils DEVICE

Hydrogel coils 90% by length

Also known as: HydroFrame, HydroFill, HydroSoft, HydroSoft 3D

Subjects with ruptured aneurysms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient is ≥ 18 and ≤ 80 years of age.
• 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.
• Patient has a baseline Hunt and Hess Score of I, II, or III.
• Patient or patient's legally authorized representative has provided written informed consent.
• Patient must be considered by the treating physician to be available for and able to complete all followup visits.
• Patient has not been previously entered into this study.

You may not qualify if:

• Inability to obtain written informed consent.
• Patient is \< 18 or \> 80 years of age.
• Patient has a baseline Hunt and Hess score of IV or V.
• Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or AVM-related.
• Target aneurysm maximum diameter is \> 15 mm or \< 2 mm.
• Target aneurysm was previously treated via clipping or coiling.
• Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques.
• Target aneurysm has not been confidently determined by the treating physician to be the source of SAH.
• Planned use of a flow diverter or intrasaccular device as a component of the target aneurysm treatment plan.
• 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.
• Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device.
• Patient has a contraindication to heparin or aspirin.
• Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.
• Patient is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician.
• Patient has a serious or life-threatening comorbidity that could confound study results.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead
• Semmes-Murphey Foundation: collaborator

Study Sites (1)

Methodist University Hospital

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adam S Arthur, MD, MPH, FACS

  Semmes-Murphey Clinic

  PRINCIPAL INVESTIGATOR

• David Fiorella, MD, PhD

  Stony Brook Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 17, 2017
• Study Start: November 27, 2017
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)