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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729740
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Penumbra Smart Coil Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 995 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
Actual Study Start Date : June 3, 2016
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : December 27, 2019

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Arms and Interventions
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Arm Intervention/treatment
Penumbra Smart System Device: Penumbra Smart Coil
Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure [ Time Frame: Immediate Post Procedure ]
  4. Number of Participants Requiring Retreatment Through Follow-up [ Time Frame: One year from enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729740


Locations
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Sponsors and Collaborators
Penumbra Inc.
  Study Documents (Full-Text)

Documents provided by Penumbra Inc.:
Study Protocol  [PDF] August 23, 2016
Statistical Analysis Plan  [PDF] January 11, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT02729740    
Other Study ID Numbers: CLP 10023
First Posted: April 6, 2016    Key Record Dates
Results First Posted: March 1, 2021
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Penumbra Inc.:
Penumbra Smart coils
PC 400
AV malformations
AV fistulae
POD
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases