The study will compare clinical and angiographic outcomes in patients receiving Hydrocoil aneurysm treatment versus patients receiving non-HydroCoil aneurysm treatment.
With prospective, randomized trials in progress evaluating the effectiveness of Hydrocoils and Cerecyte coils in comparison to bare platinum coils, the next step is a direct comparison of Hydrocoils and non-HydroCoils (Cerecyte or Platinum). Considering the increased costs to society of treatment with these new coils, it is essential that the benefits of the new technology are properly evaluated against the existing platinum coil technology in a scientifically valid manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Micro Vention Hydrogel Coils
Cerecyte or bare platinum coils
Mercy Stroke Center
Carmichael, California, United States
University of Southern California
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Occlusion rate
Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular treatment.
Time frame: 12 - 18 months
Treatment related morbidity and mortality
Treatment related morbidity and mortality, as measured by the NIH stroke scale;
Time frame: 12-18 months
Packing density
Packing density as measured by volumetric filling of the aneurysm.
Time frame: 12-18 months
Clinical outcome
Clinical outcome as measured by Modified Rankin Scale
Time frame: 6 months
Clinical Outcome
Clinical outcome as measured by the Modified Rankin scale
Time frame: 12-18 months
Re-bleed rates
Comparison of rebleed rates at 12-18 months
Time frame: 12-18 months
Re-treatment rates
Comparison of re-treatment rates at 12-18 months post treatment.
Time frame: 12-18 months
Cost of treatment
Comparison of cost of treatment.
Time frame: 12-18 months
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Saint Louis University
St Louis, Missouri, United States
St. Luke's/Roosevelt Hospital Center
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical college of South Carolina
Charleston, South Carolina, United States
University of Texas Southwest Medical Center
Dallas, Texas, United States
The Methodist Research Institute
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
...and 1 more locations