Status:
COMPLETED
Registry for Study of Coils in Intracranial Aneurysms
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Abbott
Albany Medical College
Conditions:
Cerebral Aneurysms
Eligibility:
All Genders
21-90 years
Brief Summary
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 dis...
Detailed Description
Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we will compare ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Inability to obtain informed consent.
- Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01000675
Start Date
August 1 2009
End Date
December 1 2016
Last Update
June 6 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905