Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

Completed

Conditions studied: Intracranial Aneurysms

In brief

The purpose of this study is to assess the safety and efficacy rates of the treatment of small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a type of platinum coils used to occlude aneurysms.

Key facts

Study ID

NCT02657772

Run by

University of Maryland, Baltimore

People needed

100

Starts

2013-11-01

Expected to finish

2021-03-01

Last updated by the study team

2022-03-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient is between 18 and 80 years of age (inclusive).
• Patient has a documented untreated intracranial aneurysm less than or equal to 5.0 mm in maximal dimension, ruptured or unruptured, suitable for embolization with coils.
• Target® Ultra coils may be used.
• Target aneurysm can be completely or nearly completely coiled at index procedure (No staged treatment procedures) without anticipated need for any target aneurysm reintervention after 72 hours of the index procedure. If a stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
• Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
• Patient (or patient's legally authorized representative) has provided written informed consent.
• Patient is willing and able to comply with protocol follow-up requirements.

You may not qualify if…

• Patient is <18 or >80 years old.
• Target aneurysm is felt by the physician operator to be mycotic or clearly dissecting in etiology.
• Target aneurysm is >5.0 mm maximum luminal dimension.
• Target aneurysm has been previously treated by surgery or endovascular therapy.
• Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
• Patient presents as Hunt and Hess grade V for a ruptured aneurysm.
• Patient has known hypersensitivity to platinum, tungsten, nickel, stainless steel or structurally related compounds found in Target® Ultra coils.
• Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
• Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (<24 months), comorbidities or geographical considerations.
• Patients with Moya-Moya disease, brain arteriovenous malformation(s), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm.
• Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
• Female patient has a positive pregnancy assessment at baseline, breastfeeding patient, or patient who plans to become pregnant within the 18 months following coiling.
• The following comorbidities that may confound results: (a) organ failure of kidney (b) uncorrectable coagulation abnormality.

Where it is running

• Christiana Care Health System — Newark, Delaware, United States
• WellStar Research Institute — Marietta, Georgia, United States
• University of Maryland Baltimore — Baltimore, Maryland, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Geisinger medical center — Danville, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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