Ruptured Aneurysms Treated With Hydrogel Coils

Status unconfirmed

Conditions studied: Ruptured Aneurysm

In brief

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

Key facts

Study ID

NCT03252314

Run by

Microvention-Terumo, Inc.

People needed

1000

Starts

2017-11-27

Expected to finish

2025-12-01

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• Patient is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc.
• Patient is unable to complete scheduled followup assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months.
• Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of followup.
• Patient is enrolled in another device or drug study in which participation could confound study results.

Where it is running

• Methodist University Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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