Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
215 participants
INTERVENTIONAL
2008-12-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MicroVention Hydrogel Coils
FDA approved and in common use for cerebral aneurysm treatment.
MicroVention Hydrogel coil
Micro Vention Hydrogel Coils
Non-hydrogel coils
Cerecyte or bare platinum coils (FDA approved and in common use for treatment of cerebral aneurysm).
Non-hydrogel coils
Cerecyte or bare platinum coils
Interventions
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MicroVention Hydrogel coil
Micro Vention Hydrogel Coils
Non-hydrogel coils
Cerecyte or bare platinum coils
Eligibility Criteria
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Inclusion Criteria
2. The neurointerventionalist believes that the aneurysm can be safely treated with either Cerecyte or Hydrogel.
3. Patients between (and including) 21 and 90 years of age.
4. Patient HUNT AND HESS Grade 0-3.
5. Patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
6. Aneurysm 5-20mm in maximum diameter.
7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
8. The patient has not been previously randomized into this or another related ongoing trial.
9. The aneurysm has not previously been treated (by coiling or clipping).
Exclusion Criteria
2. Target aneurysm has had previous coil treatment or surgically clipped.
3. Patient has an H\&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
4. Inability to obtain informed consent.
5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
\-
21 Years
90 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
University of Virginia
OTHER
Responsible Party
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Principal Investigators
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Avery J Evans, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Mercy Stroke Center
Carmichael, California, United States
University of Southern California
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
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
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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Other Identifiers
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13861
Identifier Type: -
Identifier Source: org_study_id