Clinical trial NCT02729740: Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Official title: SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Penumbra Smart coils
PC 400
AV malformations
AV fistulae
POD
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 995
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
timeFrame: Immediate Post Procedure
measure: Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
timeFrame: Immediate Post Procedure
measure: Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
timeFrame: Immediate Post Procedure
measure: Number of Participants Requiring Retreatment Through Follow-up
timeFrame: One year from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Southeast Alabama Medical Center
state: Alabama
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: BNI
state: Arizona
city: Tucson
country: United States
facility: Banner - University Medical Center Tucson
state: Arizona
city: Fresno
country: United States
facility: Community Regional
state: California
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy San Juan
state: California
city: Santa Barbara
country: United States
facility: Cottage Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: RIA - Swedish Medical Center
state: Colorado
city: Lakewood
country: United States
facility: St. Anthony's Hospital
state: Colorado
city: Wheat Ridge
country: United States
facility: RIA - Lutheran Medical Center
state: Colorado
city: Newark
country: United States
facility: Christiana Health
state: Delaware
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Hialeah
country: United States
facility: CARE - Palmetto
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial
state: Florida
city: Miami
country: United States
facility: Mt. Sinai Miami
state: Florida
city: Plantation
country: United States
facility: Westside Regional Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Hospital
state: Florida
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Evanston
country: United States
facility: North Shore University
state: Illinois
city: Springfield
country: United States
facility: Clinical Radiologist
state: Illinois
city: Kansas City
country: United States
facility: KUMC
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Minneapolis
country: United States
facility: HCMC
state: Minnesota
city: Minneapolis
country: United States
facility: UM-Fairview
state: Minnesota
city: Fenton
country: United States
facility: SSM Health Care
state: Missouri
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Johnson City
country: United States
facility: UHS Wilson Medical Center
state: New York
city: Manhasset
country: United States
facility: Northshore
state: New York
city: New Hartford
country: United States
facility: Faxton St. Luke's Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Toledo
country: United States
facility: St. Vincent
state: Ohio
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey's Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System, University of TN College of Medicine
state: Tennessee
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist
state: Tennessee
city: Memphis
country: United States
facility: Baptist Hospital
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Charlottesville
country: United States
facility: Dept. of Neurosurgery, Univ of VA School of Medicine
state: Virginia
city: Winchester
country: United States
facility: Valley Health Winchester
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Tacoma
country: United States
facility: Tacoma General
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Saskatoon
country: Canada
facility: Royal University
Study officials:
References:
citation: 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.
citation: 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.