Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
NCT ID: NCT02729740
Last Updated: 2021-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
995 participants
INTERVENTIONAL
2016-06-03
2019-12-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Penumbra Smart System
Penumbra Smart Coil
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care
Interventions
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Penumbra Smart Coil
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care
Eligibility Criteria
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Inclusion Criteria
* Intracranial aneurysms
* Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Exclusion Criteria
* Smart, PC 400, or POD account for less than 75% of total number of coils implanted
* Participation in another clinical investigation that could confound the evaluation of the registry device
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Locations
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Southeast Alabama Medical Center
Dothan, Alabama, United States
Banner Desert Medical Center
Mesa, Arizona, United States
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
BNI
Phoenix, Arizona, United States
Banner - University Medical Center Tucson
Tucson, Arizona, United States
Community Regional
Fresno, California, United States
Loma Linda Medical Center
Loma Linda, California, United States
Mercy San Juan
Sacramento, California, United States
Cottage Hospital
Santa Barbara, California, United States
University of Colorado
Aurora, Colorado, United States
RIA - Swedish Medical Center
Englewood, Colorado, United States
St. Anthony's Hospital
Lakewood, Colorado, United States
RIA - Lutheran Medical Center
Wheat Ridge, Colorado, United States
Christiana Health
Newark, Delaware, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, United States
CARE - Palmetto
Hialeah, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Jackson Memorial
Miami, Florida, United States
Mt. Sinai Miami
Miami, Florida, United States
Westside Regional Medical Center
Plantation, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, United States
Northwestern Memorial
Chicago, Illinois, United States
North Shore University
Evanston, Illinois, United States
Clinical Radiologist
Springfield, Illinois, United States
KUMC
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Metro Health Hospital
Wyoming, Michigan, United States
HCMC
Minneapolis, Minnesota, United States
UM-Fairview
Minneapolis, Minnesota, United States
SSM Health Care
Fenton, Missouri, United States
Overlook Medical Center
Summit, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
UHS Wilson Medical Center
Johnson City, New York, United States
Northshore
Manhasset, New York, United States
Faxton St. Luke's Hospital
New Hartford, New York, United States
Mount Sinai
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
St. Vincent
Toledo, Ohio, United States
OUHSC
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hershey's Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Palmetto Health
Columbia, South Carolina, United States
Erlanger Health System, University of TN College of Medicine
Chattanooga, Tennessee, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Methodist
Memphis, Tennessee, United States
Baptist Hospital
Memphis, Tennessee, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Houston Methodist
Houston, Texas, United States
Texas Stroke Institute
Plano, Texas, United States
Dept. of Neurosurgery, Univ of VA School of Medicine
Charlottesville, Virginia, United States
Valley Health Winchester
Winchester, Virginia, United States
Overlake Hospital
Bellevue, Washington, United States
Tacoma General
Tacoma, Washington, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Royal University
Saskatoon, , Canada
Countries
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References
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Spiotta AM, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward BK, Hawk HE, Nanda A, Zaidat OO, Sunenshine PJ, Liu KC, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM; SMART Registry Investigators. The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations. Front Neurol. 2021 Apr 13;12:637551. doi: 10.3389/fneur.2021.637551. eCollection 2021.
Starke RM, Park MS, Bellon R, Bohnstedt B, Schirmer CM, De Leacy R, Fiorella D, Yoo AJ, Spiotta AM; SMART Registry Investigators. Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis. J Neurointerv Surg. 2022 Jan;14(1):neurintsurg-2020-016943. doi: 10.1136/neurintsurg-2020-016943. Epub 2021 Feb 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLP 10023
Identifier Type: -
Identifier Source: org_study_id
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