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

  • Canada
      • Saskatoon, Canada
        • Royal University
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Southeast Alabama Medical Center
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center - Phoenix
      • Phoenix, Arizona, United States, 85260
        • BNI
      • Tucson, Arizona, United States, 85724
        • Banner - University Medical Center Tucson
    • California
      • Fresno, California, United States, 93721
        • Community Regional
      • Loma Linda, California, United States, 92354
        • Loma Linda Medical Center
      • Sacramento, California, United States, 95608
        • Mercy San Juan
      • Santa Barbara, California, United States, 93105
        • Cottage Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80112
        • RIA - Swedish Medical Center
      • Lakewood, Colorado, United States, 80228
        • St. Anthony's Hospital
      • Wheat Ridge, Colorado, United States, 80112
        • RIA - Lutheran Medical Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Health
    • Florida
      • Fort Pierce, Florida, United States, 34950
        • Lawnwood Regional Medical Center
      • Hialeah, Florida, United States, 33016
        • CARE - Palmetto
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Miami, Florida, United States, 33136
        • Jackson Memorial
      • Miami, Florida, United States, 33140
        • Mt. Sinai Miami
      • Plantation, Florida, United States, 33324
        • Westside Regional Medical Center
      • Saint Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
      • Tampa, Florida, United States, 33620
        • University of South Florida
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
    • Idaho
      • Boise, Idaho, United States, 83706
        • St. Alphonsus Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial
      • Evanston, Illinois, United States, 60631
        • North Shore University
      • Springfield, Illinois, United States, 62704
        • Clinical Radiologist
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • KUMC
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • HCMC
      • Minneapolis, Minnesota, United States, 55455
        • UM-Fairview
    • Missouri
      • Fenton, Missouri, United States, 63026
        • SSM Health Care
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Overlook Medical Center
    • New York
      • Buffalo, New York, United States, 14210
        • Kaleida Health
      • Johnson City, New York, United States, 13790
        • UHS Wilson Medical Center
      • Manhasset, New York, United States, 11030
        • Northshore
      • New Hartford, New York, United States, 13502
        • Faxton St. Luke's Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10029
        • Mount Sinai
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Toledo, Ohio, United States, 43608
        • St. Vincent
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OUHSC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Hershey's Medical Center
      • Philadelphia, Pennsylvania, United States, 19144
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System, University of TN College of Medicine
      • Knoxville, Tennessee, United States, 37916
        • Fort Sanders Regional Medical Center
      • Memphis, Tennessee, United States, 38104
        • Methodist
      • Memphis, Tennessee, United States, 38120
        • Baptist Hospital
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Plano, Texas, United States, 75075
        • Texas Stroke Institute
    • Virginia
      • Charlottesville, Virginia, United States, 229808
        • Dept. of Neurosurgery, Univ of VA School of Medicine
      • Winchester, Virginia, United States, 22601
        • Valley Health Winchester
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Hospital
      • Tacoma, Washington, United States, 98405
        • Tacoma General
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

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
Other: Penumbra Smart System
Device: Penumbra Smart Coil
Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care

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
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
Time Frame: Immediate Post Procedure
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
Time Frame: Immediate Post Procedure
Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
Time Frame: One year from enrollment
One year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

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

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

Keywords

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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