Registry for Study of Coils in Intracranial Aneurysms

Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)

Sponsors

Lead Sponsor: Mayo Clinic

Collaborator: Abbott
Albany Medical College
Asan Medical Center
Baylor University
Bronson Methodist Hospital
Capital Health, Canada
The Cleveland Clinic
Dalhousie University
Fudan University
Fort Sanders Regional Medical Center
JFK Medical Center, Florida
Kobe City Medical Center
Methodist Research Institute, Indianapolis
Medical University of South Carolina
Providence Health & Services
Scott and White Hospital & Clinic
Stony Brook University
Thomas Jefferson University
Royal University Hospital Foundation
University of California, Los Angeles
University of Florida
University of Maryland, College Park
University of Oklahoma
University of Southern California
Washington University School of Medicine

Source Mayo Clinic
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.

Overall Status Completed
Start Date 2009-08-01
Completion Date 2016-12-01
Primary Completion Date 2013-06-01
Study Type Observational
Primary Outcome
Measure Time Frame
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. 6 - 18 months post coiling
Secondary Outcome
Measure Time Frame
HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. 6 - 18 months post coiling
Enrollment 114
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

21 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David F Kallmes, MD Principal Investigator Mayo Clinic
Location
Facility: Mayo Clinic
Location Countries

United States

Verification Date

2019-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: David F. Kallmes

Investigator Title: David F Kallmes, MD, Mayo Clinic

Keywords
Has Expanded Access No
Condition Browse
Acronym Gel-the-nec
Study Design Info

Observational Model: Other

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News