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The Jetstream G3™ Calcium Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01273623
First received: December 20, 2010
Last updated: October 19, 2015
Last verified: October 2015
Results First Received: April 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Intervention: Device: Jetstream Atherectomy 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
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Reporting Groups
  Description
Single Arm subjects with calcified peripheral arterial lesions determined by intravascular ultrasound

Participant Flow:   Overall Study
    Single Arm  
STARTED     55 [1]
COMPLETED     26 [2]
NOT COMPLETED     29  
did not meet IVUS criteria                 29  
[1] met angiographic criteria
[2] met IVUS criteria



  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
Single Arm subjects with calcified peripheral arterial lesions determined by intravascular ultrasound

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean (Standard Deviation)
  73  (11)  
Gender  
[units: participants]
 
Female     9  
Male     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Luminal Area Change   [ Time Frame: Day 0 ]

2.  Secondary:   Adjunctive Therapy Use   [ Time Frame: Day 0 ]

3.  Secondary:   Residual Diameter Stenosis   [ Time Frame: Day 0 ]


  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: Susanna Kennedy
Organization: Boston Scientific
phone: 763.494.2601
e-mail: susanna.kennedy@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01273623     History of Changes
Other Study ID Numbers: D1139
Study First Received: December 20, 2010
Results First Received: April 16, 2015
Last Updated: October 19, 2015
Health Authority: United States: Institutional Review Board