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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott
Albany Medical College
Asan Medical Center
Baylor University
Bronson Methodist Hospital
Capital Health, Canada
The Cleveland Clinic
Dalhousie University
First Affiliated Hospital
Fudan University
Fort Sanders Regional Medical Center
JFK Medical Center, Florida
Kobe City Medical Center
Methodist Research Institute, Indianapolis
MUSC
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
ClinicalTrials.gov Identifier:
NCT01000675
First received: October 22, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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
Cerebral Aneurysms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil (Gel-the-nec)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure. [ Time Frame: 6 - 18 months post coiling ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000675

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
First Affiliated Hospital
Fudan University
Fort Sanders Regional Medical Center
JFK Medical Center, Florida
Kobe City Medical Center
Methodist Research Institute, Indianapolis
MUSC
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

No publications provided

Responsible Party: David F. Kallmes, David F Kallmes, MD, Mayo Clinic, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01000675     History of Changes
Other Study ID Numbers: 09-002933
Study First Received: October 22, 2009
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
aneurysm
coils

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014