Clinical trial NCT01000675: Registry for Study of Coils in Intracranial Aneurysms
Official title: Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Aneurysms
Keywords: aneurysm
coils
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Abbott
name: Albany Medical College
name: Asan Medical Center
name: Baylor University
name: Bronson Methodist Hospital
name: Capital Health, Canada
name: The Cleveland Clinic
name: Dalhousie University
name: Fudan University
name: Fort Sanders Regional Medical Center
name: JFK Medical Center, Florida
name: Kobe City Medical Center
name: Methodist Research Institute, Indianapolis
name: Medical University of South Carolina
name: Providence Health & Services
name: Scott and White Hospital & Clinic
name: Stony Brook University
name: Thomas Jefferson University
name: Royal University Hospital Foundation
name: University of California, Los Angeles
name: University of Florida
name: University of Maryland
name: University of Oklahoma
name: University of Southern California
name: Washington University School of Medicine
First posted: 2009-10-23
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.

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 disadvantages of the HydroSoft, and to inform future randomized trials.

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 recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils. This registry is designed to achieve 80% power to detect a minimally clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms compared with bare platinum coils. Based on recent, prospective, randomized trials assessing both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates, respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically, a "minimally clinically relevant difference" is on the order of a 30% diminution in a given undesirable outcome. As such, the registry is well powered to detect this minimally clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils versus 25% for the historical control group).

Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. Success of this aim is defined as ease of placement of the HydroSoft device, without need for coil removal and subsequent "finishing" with a bare platinum coil.

Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is associated with risks of thromboembolism similar to that with other coil types, on the order of 3-5% or less.

Eligibility criteria: Inclusion Criteria:

1. Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
2. Patient age: patients aged between 21 and 90 years will be eligible.
3. Patient HUNT AND HESS Grade 0-3.
4. 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.
5. Aneurysm 3-15mm in maximum diameter.
6. Patient is willing and able to return for follow up angiography or MRA between 6-18 months.
7. The patient has not been previously entered into this registry
8. The aneurysm has not previously been treated (by coiling or clipping).

Exclusion Criteria:

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

Primary outcomes:
measure: We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils.
timeFrame: 6 - 18 months post coiling
Secondary outcomes:
measure: HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
timeFrame: 6 - 18 months post coiling
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David F Kallmes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brinjikji W, Amar AP, Delgado Almandoz JE, Diaz O, Jabbour P, Hanel R, Hui F, Kelly M, Layton KD, Miller JW, Levy E, Moran C, Suh DC, Woo H, Sellar R, Ho B, Evans A, Kallmes DF. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30.