Registry for Study of Coils in Intracranial Aneurysms

Completed

Conditions studied: Cerebral Aneurysms

In brief

The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.

Key facts

Study ID

NCT01000675

Run by

Mayo Clinic

People needed

114

Starts

2009-08-01

Expected to finish

2016-12-01

Last updated by the study team

2019-06-06

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
• Patient age: patients aged between 21 and 90 years will be eligible.
• Patient HUNT AND HESS Grade 0-3.
• Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
• Aneurysm 3-15mm in maximum diameter.
• Patient is willing and able to return for follow up angiography or MRA between 6-18 months.
• The patient has not been previously entered into this registry
• The aneurysm has not previously been treated (by coiling or clipping).

You may not qualify if…

• Inability to obtain informed consent.
• Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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