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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01118117
First Posted: May 6, 2010
Last Update Posted: December 12, 2016
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.
Collaborators:
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Terumo Medical Corporation
Results First Submitted: June 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 261 subjects were enrolled in the pivotal study cohort. An additional 15 subjects were implanted with a single, 150mm stent as part of a long length stent (LL) sub-study. The LL sub-study included safety data through 30 days post-procedure and was analyzed separately from the pivotal study cohort.

Reporting Groups
  Description
Misago™ Self-Expanding Stent System Subjects received treatment with the Misago™ Self-Expanding Stent
Long Length Stent Sub-Study Cohort Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent

Participant Flow:   Overall Study
    Misago™ Self-Expanding Stent System   Long Length Stent Sub-Study Cohort
STARTED   261   15 
COMPLETED   240   15 
NOT COMPLETED   21   0 
Death                8                0 
Lost to Follow-up                6                0 
Missed 12 Month Visit                7                0 



  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
Misago™ Self-Expanding Stent System Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
Long Length (150mm) Misago™ Self-Expanding Stent System Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
Total Total of all reporting groups

Baseline Measures
   Misago™ Self-Expanding Stent System   Long Length (150mm) Misago™ Self-Expanding Stent System   Total 
Overall Participants Analyzed 
[Units: Participants]
 261   15   276 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 69.3  (10)   70.7  (10.9)   NA [1] 
[1] Combined analysis of pivotal cohort and LL sub-study cohort was not completed
Gender 
[Units: Participants]
     
Female   92   8   100 
Male   169   7   176 
Region of Enrollment 
[Units: Participants]
     
United States   201   15   216 
Japan   50   0   50 
Taiwan   9   0   9 
Korea, Republic of   1   0   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 Program Manager
Organization: Terumo Medical Corporation
phone: 201-398-3283
e-mail: adam.thompson@terumomedical.com


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

Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT01118117     History of Changes
Other Study ID Numbers: TIS2009-02
First Submitted: May 4, 2010
First Posted: May 6, 2010
Results First Submitted: June 18, 2015
Results First Posted: July 14, 2015
Last Update Posted: December 12, 2016