A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
NCT ID: NCT03383666
Last Updated: 2023-06-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
21 participants
INTERVENTIONAL
2018-10-15
2021-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.
PulseRider® Aneurysm Neck Reconstruction Device
Neck Reconstruction Device
Interventions
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PulseRider® Aneurysm Neck Reconstruction Device
Neck Reconstruction Device
Eligibility Criteria
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Inclusion Criteria
2. The subject is between 18 and 80 years of age the time of consent
3. Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
4. In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated
Exclusion Criteria
2. Subarachnoid Hemorrhage (SAH) within the last 60 days
3. Irreversible bleeding disorder
4. Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
5. A history of contrast allergy that cannot be medically controlled
6. Known allergy to nickel
7. Relative contraindication to angiography
8. Woman of child-bearing potential who cannot provide a negative pregnancy test
9. Current involvement in a study for another investigational product
10. Patient and / or family considering a move from this geographical location at the time of consent
11. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
18 Years
80 Years
ALL
No
Sponsors
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Pulsar Vascular
INDUSTRY
Responsible Party
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Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Mount Sinai Hospital
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CSC_2017-01
Identifier Type: -
Identifier Source: org_study_id
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