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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000675
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
David F. Kallmes, Mayo Clinic

Tracking Information
First Submitted Date October 22, 2009
First Posted Date October 23, 2009
Last Update Posted Date June 6, 2019
Actual Study Start Date August 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2009)
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. [ Time Frame: 6 - 18 months post coiling ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2009)
HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. [ Time Frame: 6 - 18 months post coiling ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry for Study of Coils in Intracranial Aneurysms
Official Title Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.
Condition Cerebral Aneurysms
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 8, 2015)
114
Original Estimated Enrollment
 (submitted: October 22, 2009)
400
Actual Study Completion Date December 2016
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01000675
Other Study ID Numbers 09-002933
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David F. Kallmes, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators
  • 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
Investigators
Principal Investigator: David F Kallmes, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2019