Registry for Study of Coils in Intracranial Aneurysms (Gel-the-nec)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysms

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Medical University of South Carolina; Washington University School of Medicine; University of California, Los Angeles; University of Maryland; Fudan University; University of Oklahoma; The Cleveland Clinic; Stony Brook University; University of Florida; University of Southern California; Asan Medical Center; Dalhousie University; Methodist Research Institute, Indianapolis; Thomas Jefferson University; Abbott; Baylor University; Providence Health & Services; Royal University Hospital Foundation; Scott and White Hospital & Clinic; Albany Medical College; Capital Health, Canada; Bronson Methodist Hospital; Fort Sanders Regional Medical Center; JFK Medical Center, Florida; Kobe City Medical Center
• Investigators: Principal Investigator: David F Kallmes, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 23, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: aneurysm; coils
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 09-002933