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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UNKNOWN
150 participants
OBSERVATIONAL
2013-02-28
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Target 360°, 2D, Nano Coils
Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.
Target 360°, 2D Coils, Nano Coils
Interventions
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Target 360°, 2D Coils, Nano Coils
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
3. (NEW NANO arm ONLY) Target aneurysm is ≤7mm.
4. Patient has a Hunt and Hess Score of 3 or less.
5. Patient has a premorbid mRS of 3 or less.
6. Patient or patient's legally authorized representative has provided written informed consent.
7. Patient is willing to and can comply with study follow-up requirements.
Exclusion Criteria
2. Dissecting aneurysm.
3. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
4. Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.
5. (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of \<25% Stryker Target® 2nd generation Nano Coils.
6. Target aneurysm is fusiform.
7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
18 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Mercy Health Ohio
OTHER
Responsible Party
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Dr. Osama O. Zaidat
Medical Director, Neuroscience and Stroke Programs
Principal Investigators
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Osama O Zaidat, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mercy Health St. Vincent Medical Center
Locations
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University of Arizona
Phoenix, Arizona, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
McLaren Health
Flint, Michigan, United States
SSM DePaul Health Center
St Louis, Missouri, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
Greenville Health System
Greenville, South Carolina, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Zaidat OO, Castonguay AC, Rai AT, Badruddin A, Mack WJ, Alshekhlee AK, Shah QA, Hussain SI, Kabbani MR, Bulsara KR, Taqi AM, Janardhan V, Patterson MS, Nordhaus BL, Elijovich L, Puri AS. TARGET(R) Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results. Front Neurol. 2019 Jul 9;10:737. doi: 10.3389/fneur.2019.00737. eCollection 2019.
Other Identifiers
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19180
Identifier Type: -
Identifier Source: org_study_id
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