Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01541254
First received: February 15, 2012
Last updated: September 6, 2014
Last verified: September 2014
Results First Received: September 5, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intracranial Aneurysms
Intervention: Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Arm

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)


Participant Flow:   Overall Study
    Single Arm  
STARTED     36  
COMPLETED     30  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
excluded - metal allergy                 1  
enrolled after study closed                 1  
GI bleed prior to procedure                 1  
stent not required                 1  
alternate stent used                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Arm Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean ± Standard Deviation
  58.6  ± 10.6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     11  
Gender  
[units: participants]
 
Female     23  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
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1.  Primary:   Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)   [ Time Frame: 6 months ± 4 weeks ]

2.  Primary:   Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months   [ Time Frame: 30 days-6 months ]

3.  Secondary:   Parent Artery Patency Measured Angiographically at 6 Months   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Successful Delivery of the LVIS™ Device Measures by Technical Success   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Significant Stenosis(>50%) of the Treated Artery at 6 Months   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Stent Migration at 6 Months   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Device and Procedure Related Serious Adverse Events   [ Time Frame: Day 1-6months(± 4 months) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Unplanned Embolization Coiling Within 6 Months   [ Time Frame: Day 1-6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mary Schmitz
Organization: MicroVention, Inc.
phone: 714-247-8025
e-mail: mary.schmitz@microvention.com


No publications provided


Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01541254     History of Changes
Other Study ID Numbers: G110014
Study First Received: February 15, 2012
Results First Received: September 5, 2014
Last Updated: September 6, 2014
Health Authority: United States: Food and Drug Administration