A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery (OSPREY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Terumo Medical Corporation
ClinicalTrials.gov Identifier:
NCT01118117
First received: May 4, 2010
Last updated: June 18, 2015
Last verified: June 2015
Results First Received: June 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Intervention: Device: Misago™ Self-Expanding Stent System

  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
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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
Non-Randomized Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)

Participant Flow:   Overall Study
    Non-Randomized  
STARTED     261  
COMPLETED     240  
NOT COMPLETED     21  
Death                 8  
Lost to Follow-up                 6  
Missed 12 Month Visit                 7  



  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.
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Reporting Groups
  Description
Non-Randomized Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)

Baseline Measures
    Non-Randomized  
Number of Participants  
[units: participants]
  261  
Age  
[units: years]
Mean (Standard Deviation)
  69.3  (10)  
Gender  
[units: participants]
 
Female     92  
Male     169  
Region of Enrollment  
[units: participants]
 
United States     201  
Japan     50  
Taiwan     9  
Korea, Republic of     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Effectiveness Endpoint   [ Time Frame: 12 Months post-procedure ]

2.  Primary:   Primary Safety Endpoint   [ Time Frame: 30 days post-procedure ]

3.  Secondary:   Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort   [ Time Frame: 12 Months post-procedure ]

4.  Secondary:   Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort   [ Time Frame: 12 Months post-procedure ]

5.  Secondary:   Occurrence of Target Lesion Revascularization   [ Time Frame: 12 Months post-procedure ]

6.  Secondary:   Device Related Peri-Procedural Complications   [ Time Frame: Prior to Hosptial Discharge ]

7.  Secondary:   Technical Success   [ Time Frame: Intra-procedure ]

8.  Secondary:   Procedural Success   [ Time Frame: Intra-procedure ]

9.  Secondary:   Clinical Success   [ Time Frame: 30 days post-procedure ]

10.  Secondary:   Major Adverse Events (MAEs) Through 12 Months Post-procedure   [ Time Frame: 12 Months post-procedure ]

11.  Secondary:   Stent Fracture at 12 Months   [ Time Frame: 12 Months post-procedure ]


  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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Adam Thompson, Clinical Project Manager
Organization: Terumo Medical Corporation
phone: 201-398-3283
e-mail: adam.thompson@terumomedical.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT01118117     History of Changes
Other Study ID Numbers: TIS2009-02
Study First Received: May 4, 2010
Results First Received: June 18, 2015
Last Updated: June 18, 2015
Health Authority: United States: Food and Drug Administration