search
Back to results

Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)

Primary Purpose

Intracranial Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Penumbra Smart Coil
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southeast Alabama Medical Center
  • Banner Desert Medical Center
  • Banner University Medical Center - Phoenix
  • BNI
  • Banner - University Medical Center Tucson
  • Community Regional
  • Loma Linda Medical Center
  • Mercy San Juan
  • Cottage Hospital
  • University of Colorado
  • RIA - Swedish Medical Center
  • St. Anthony's Hospital
  • RIA - Lutheran Medical Center
  • Christiana Health
  • Lawnwood Regional Medical Center
  • CARE - Palmetto
  • Memorial Healthcare System
  • Baptist Medical Center
  • Mayo Clinic Jacksonville
  • Jackson Memorial
  • Mt. Sinai Miami
  • Westside Regional Medical Center
  • Bayfront Medical Center
  • University of South Florida
  • St. Mary's Hospital
  • WellStar Kennestone Hospital
  • St. Alphonsus Regional Medical Center
  • Northwestern Memorial
  • North Shore University
  • Clinical Radiologist
  • KUMC
  • University of Louisville
  • Metro Health Hospital
  • HCMC
  • UM-Fairview
  • SSM Health Care
  • Overlook Medical Center
  • Kaleida Health
  • UHS Wilson Medical Center
  • Northshore
  • Faxton St. Luke's Hospital
  • Mount Sinai
  • Weill Cornell Medicine
  • University of Rochester Medical Center
  • Stony Brook University
  • Wake Forest Baptist Health
  • University Hospitals Cleveland Medical Center
  • St. Vincent
  • OUHSC
  • Lehigh Valley Hospital
  • Geisinger Medical Center
  • Hershey's Medical Center
  • Thomas Jefferson University
  • Allegheny General
  • MUSC
  • Palmetto Health
  • Erlanger Health System, University of TN College of Medicine
  • Fort Sanders Regional Medical Center
  • Methodist
  • Baptist Hospital
  • Valley Baptist Medical Center
  • Houston Methodist
  • Texas Stroke Institute
  • Dept. of Neurosurgery, Univ of VA School of Medicine
  • Valley Health Winchester
  • Overlake Hospital
  • Tacoma General
  • St. Mary's Medical Center
  • West Virginia University Hospital
  • Gundersen Lutheran Medical Center
  • Aurora St. Luke's Medical Center
  • Royal University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Penumbra Smart System

Arm Description

Outcomes

Primary Outcome Measures

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.
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Re-access attempts due to catheter kick-out across all coils
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Number of Participants Requiring Retreatment Through Follow-up

Secondary Outcome Measures

Full Information

First Posted
March 15, 2016
Last Updated
February 26, 2021
Sponsor
Penumbra Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02729740
Brief Title
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Acronym
SMART
Official Title
SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2016 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Penumbra Smart coils, PC 400, AV malformations, AV fistulae, POD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
995 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Penumbra Smart System
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Penumbra Smart Coil
Intervention Type
Device
Intervention Name(s)
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Intervention Description
Other Penumbra Coils available as standard of care
Primary Outcome Measure Information:
Title
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
Description
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Time Frame
Immediate Post Procedure
Title
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
Description
Re-access attempts due to catheter kick-out across all coils
Time Frame
Immediate Post Procedure
Title
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
Time Frame
Immediate Post Procedure
Title
Number of Participants Requiring Retreatment Through Follow-up
Time Frame
One year from enrollment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Southeast Alabama Medical Center
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Banner Desert Medical Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Banner University Medical Center - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
BNI
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Banner - University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Community Regional
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Mercy San Juan
City
Sacramento
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
RIA - Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
St. Anthony's Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
RIA - Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Christiana Health
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lawnwood Regional Medical Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
CARE - Palmetto
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mt. Sinai Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Westside Regional Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Bayfront Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
St. Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Northwestern Memorial
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
North Shore University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
Clinical Radiologist
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
KUMC
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
HCMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
UM-Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
SSM Health Care
City
Fenton
State/Province
Missouri
ZIP/Postal Code
63026
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14210
Country
United States
Facility Name
UHS Wilson Medical Center
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Northshore
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Faxton St. Luke's Hospital
City
New Hartford
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
St. Vincent
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Hershey's Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
Allegheny General
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Erlanger Health System, University of TN College of Medicine
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Fort Sanders Regional Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Methodist
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baptist Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Stroke Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Dept. of Neurosurgery, Univ of VA School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
229808
Country
United States
Facility Name
Valley Health Winchester
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Overlake Hospital
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Tacoma General
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Royal University
City
Saskatoon
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33927680
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.
Results Reference
derived
PubMed Identifier
33593799
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.
Results Reference
derived

Learn more about this trial

Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

We'll reach out to this number within 24 hrs