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

• ClinicalTrials.gov Identifier: NCT01000675
• Recruitment Status: Completed
• First Posted: October 23, 2009
• Last Update Posted: June 6, 2019
• 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; University of Oklahoma; University of Southern California; Washington University School of Medicine
• Information provided by (Responsible Party): David F. Kallmes, Mayo Clinic

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 114 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)
• Actual Study Start Date: August 2009
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: December 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. [ Time Frame: 6 - 18 months post coiling ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

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

University of Oklahoma

University of Southern California

Washington University School of Medicine

Investigators

• Principal Investigator: David F Kallmes, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: David F. Kallmes, David F Kallmes, MD, Mayo Clinic, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01000675
• Other Study ID Numbers: 09-002933
• First Posted: October 23, 2009
• Last Update Posted: June 6, 2019
• Last Verified: June 2019

Keywords provided by David F. Kallmes, Mayo Clinic:

aneurysm; coils

Additional relevant MeSH terms:

Intracranial Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases