Registry for Study of Coils in Intracranial Aneurysms

Cerebral Aneurysms Clinical Trial

— Gel-the-nec  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000675
• Other study ID #: 09-002933
• Status: Completed
• Start date: August 2009
• Est. completion date: December 2016

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2016
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysms
• Intracranial Aneurysm

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (26)

Lead Sponsor

Collaborator

Mayo Clinic

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.		6 - 18 months post coiling

External Links

•   Mayo Clinic Clinical Trials