Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
SMART
SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
1 other identifier
interventional
995
2 countries
72
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedStudy Start
First participant enrolled
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2019
CompletedResults Posted
Study results publicly available
March 1, 2021
CompletedMarch 1, 2021
February 1, 2021
3.6 years
March 15, 2016
December 17, 2020
February 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Immediate Post Procedure
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Re-access attempts due to catheter kick-out across all coils
Immediate Post Procedure
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
One year from enrollment
Study Arms (1)
Penumbra Smart System
OTHERInterventions
Other Penumbra Coils available as standard of care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (72)
Southeast Alabama Medical Center
Dothan, Alabama, 36301, United States
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Banner University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
BNI
Phoenix, Arizona, 85260, United States
Banner - University Medical Center Tucson
Tucson, Arizona, 85724, United States
Community Regional
Fresno, California, 93721, United States
Loma Linda Medical Center
Loma Linda, California, 92354, United States
Mercy San Juan
Sacramento, California, 95608, United States
Cottage Hospital
Santa Barbara, California, 93105, United States
University of Colorado
Aurora, Colorado, 80045, United States
RIA - Swedish Medical Center
Englewood, Colorado, 80112, United States
St. Anthony's Hospital
Lakewood, Colorado, 80228, United States
RIA - Lutheran Medical Center
Wheat Ridge, Colorado, 80112, United States
Christiana Health
Newark, Delaware, 19713, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950, United States
CARE - Palmetto
Hialeah, Florida, 33016, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Jackson Memorial
Miami, Florida, 33136, United States
Mt. Sinai Miami
Miami, Florida, 33140, United States
Westside Regional Medical Center
Plantation, Florida, 33324, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, United States
University of South Florida
Tampa, Florida, 33620, United States
St. Mary's Hospital
West Palm Beach, Florida, 33407, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Northwestern Memorial
Chicago, Illinois, 60611, United States
North Shore University
Evanston, Illinois, 60631, United States
Clinical Radiologist
Springfield, Illinois, 62704, United States
KUMC
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40292, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
HCMC
Minneapolis, Minnesota, 55415, United States
UM-Fairview
Minneapolis, Minnesota, 55455, United States
SSM Health Care
Fenton, Missouri, 63026, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Kaleida Health
Buffalo, New York, 14210, United States
UHS Wilson Medical Center
Johnson City, New York, 13790, United States
Northshore
Manhasset, New York, 11030, United States
Faxton St. Luke's Hospital
New Hartford, New York, 13502, United States
Mount Sinai
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
St. Vincent
Toledo, Ohio, 43608, United States
OUHSC
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Hershey's Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144, United States
Allegheny General
Pittsburgh, Pennsylvania, 15212, United States
MUSC
Charleston, South Carolina, 29425, United States
Palmetto Health
Columbia, South Carolina, 29203, United States
Erlanger Health System, University of TN College of Medicine
Chattanooga, Tennessee, 37403, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist
Memphis, Tennessee, 38104, United States
Baptist Hospital
Memphis, Tennessee, 38120, United States
Valley Baptist Medical Center
Harlingen, Texas, 78550, United States
Houston Methodist
Houston, Texas, 77030, United States
Texas Stroke Institute
Plano, Texas, 75075, United States
Dept. of Neurosurgery, Univ of VA School of Medicine
Charlottesville, Virginia, 229808, United States
Valley Health Winchester
Winchester, Virginia, 22601, United States
Overlake Hospital
Bellevue, Washington, 98004, United States
Tacoma General
Tacoma, Washington, 98405, United States
St. Mary's Medical Center
Huntington, West Virginia, 25702, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Royal University
Saskatoon, Canada
Related Publications (3)
Ashouri Y, Paul AR, AlMajali M, Chaudhari A, Lin E, Park MS, Bellon RJ, Bohnstedt BN, Yoo AJ, Schirmer CM, DeLeacy RA, Fiorella DJ, Woodward K, Hawk HE, Nanda A, Sunenshine PJ, Kabbani MR, Snyder KV, Sivapatham T, Dumont TM, Reeves AR, Starke RM, Spiotta AM, Zaidat OO. Large and giant intracranial aneurysms: outcomes from the multicenter prospective SMART coils registry. Front Neurol. 2026 Jan 14;16:1670622. doi: 10.3389/fneur.2025.1670622. eCollection 2025.
PMID: 41613189DERIVEDSpiotta 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.
PMID: 33927680DERIVEDStarke 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.
PMID: 33593799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- Penumbra, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
April 6, 2016
Study Start
June 3, 2016
Primary Completion
December 27, 2019
Study Completion
December 27, 2019
Last Updated
March 1, 2021
Results First Posted
March 1, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share