Registry for Study of Coils in Intracranial Aneurysms

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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


Primary Outcome

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.

Secondary Outcome

 HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.

Condition

Cerebral Aneurysms



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

114

Start Date

August 2009

Completion Date

December 2016

Primary Completion Date

June 2013

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.
      

Gender

All

Ages

21 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

David F Kallmes, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01000675

Organization ID

09-002933


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic

Collaborators

 Abbott

Study Sponsor

David F Kallmes, MD, Principal Investigator, Mayo Clinic


Verification Date

June 2019