- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729740
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)
February 26, 2021 updated by: Penumbra Inc.
SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®).
Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up.
Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled.
It is anticipated patient enrollment will take 3 years.
All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
Study Type
Interventional
Enrollment (Actual)
995
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saskatoon, Canada
- Royal University
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Alabama
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Dothan, Alabama, United States, 36301
- Southeast Alabama Medical Center
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Arizona
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Mesa, Arizona, United States, 85202
- Banner Desert Medical Center
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Phoenix, Arizona, United States, 85006
- Banner University Medical Center - Phoenix
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Phoenix, Arizona, United States, 85260
- BNI
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Tucson, Arizona, United States, 85724
- Banner - University Medical Center Tucson
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California
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Fresno, California, United States, 93721
- Community Regional
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Loma Linda, California, United States, 92354
- Loma Linda Medical Center
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Sacramento, California, United States, 95608
- Mercy San Juan
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Santa Barbara, California, United States, 93105
- Cottage Hospital
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Englewood, Colorado, United States, 80112
- RIA - Swedish Medical Center
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Lakewood, Colorado, United States, 80228
- St. Anthony's Hospital
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Wheat Ridge, Colorado, United States, 80112
- RIA - Lutheran Medical Center
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Delaware
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Newark, Delaware, United States, 19713
- Christiana Health
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Florida
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Fort Pierce, Florida, United States, 34950
- Lawnwood Regional Medical Center
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Hialeah, Florida, United States, 33016
- CARE - Palmetto
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Hollywood, Florida, United States, 33021
- Memorial Healthcare System
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
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Jacksonville, Florida, United States, 32207
- Baptist Medical Center
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Miami, Florida, United States, 33136
- Jackson Memorial
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Miami, Florida, United States, 33140
- Mt. Sinai Miami
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Plantation, Florida, United States, 33324
- Westside Regional Medical Center
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Saint Petersburg, Florida, United States, 33701
- Bayfront Medical Center
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Tampa, Florida, United States, 33620
- University of South Florida
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West Palm Beach, Florida, United States, 33407
- St. Mary's Hospital
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Georgia
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Marietta, Georgia, United States, 30060
- Wellstar Kennestone Hospital
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Idaho
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Boise, Idaho, United States, 83706
- St. Alphonsus Regional Medical Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial
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Evanston, Illinois, United States, 60631
- North Shore University
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Springfield, Illinois, United States, 62704
- Clinical Radiologist
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Kansas
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Kansas City, Kansas, United States, 66160
- KUMC
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Kentucky
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Louisville, Kentucky, United States, 40292
- University of Louisville
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Michigan
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Wyoming, Michigan, United States, 49519
- Metro Health Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- HCMC
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Minneapolis, Minnesota, United States, 55455
- UM-Fairview
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Missouri
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Fenton, Missouri, United States, 63026
- SSM Health Care
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New Jersey
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Summit, New Jersey, United States, 07901
- Overlook Medical Center
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New York
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Buffalo, New York, United States, 14210
- Kaleida Health
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Johnson City, New York, United States, 13790
- UHS Wilson Medical Center
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Manhasset, New York, United States, 11030
- Northshore
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New Hartford, New York, United States, 13502
- Faxton St. Luke's Hospital
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New York, New York, United States, 10065
- Weill Cornell Medicine
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New York, New York, United States, 10029
- Mount Sinai
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Stony Brook, New York, United States, 11794
- Stony Brook University
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Toledo, Ohio, United States, 43608
- St. Vincent
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- OUHSC
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, United States, 17033
- Hershey's Medical Center
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Philadelphia, Pennsylvania, United States, 19144
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General
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South Carolina
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Charleston, South Carolina, United States, 29425
- MUSC
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Columbia, South Carolina, United States, 29203
- Palmetto Health
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Erlanger Health System, University of TN College of Medicine
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Knoxville, Tennessee, United States, 37916
- Fort Sanders Regional Medical Center
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Memphis, Tennessee, United States, 38104
- Methodist
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Memphis, Tennessee, United States, 38120
- Baptist Hospital
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Texas
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Harlingen, Texas, United States, 78550
- Valley Baptist Medical Center
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Houston, Texas, United States, 77030
- Houston Methodist
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Plano, Texas, United States, 75075
- Texas Stroke Institute
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Virginia
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Charlottesville, Virginia, United States, 229808
- Dept. of Neurosurgery, Univ of VA School of Medicine
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Winchester, Virginia, United States, 22601
- Valley Health Winchester
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Washington
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Bellevue, Washington, United States, 98004
- Overlake Hospital
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Tacoma, Washington, United States, 98405
- Tacoma General
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West Virginia
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Huntington, West Virginia, United States, 25702
- St. Mary's Medical Center
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Morgantown, West Virginia, United States, 26506
- West Virginia University Hospital
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, United States, 53215
- Aurora St. Luke's Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Exclusion Criteria:
- Life expectancy less than one year
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Penumbra Smart System
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Other Penumbra Coils available as standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Time Frame: Immediate Post Procedure
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Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
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Immediate Post Procedure
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Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Time Frame: Immediate Post Procedure
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Re-access attempts due to catheter kick-out across all coils
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Immediate Post Procedure
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Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Time Frame: Immediate Post Procedure
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Immediate Post Procedure
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Number of Participants Requiring Retreatment Through Follow-up
Time Frame: One year from enrollment
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One year from enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2016
Primary Completion (Actual)
December 27, 2019
Study Completion (Actual)
December 27, 2019
Study Registration Dates
First Submitted
March 15, 2016
First Submitted That Met QC Criteria
April 5, 2016
First Posted (Estimate)
April 6, 2016
Study Record Updates
Last Update Posted (Actual)
March 1, 2021
Last Update Submitted That Met QC Criteria
February 26, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP 10023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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