LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (LEVANT I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00930813
First received: June 30, 2009
Last updated: November 17, 2015
Last verified: November 2015
Results First Received: August 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Atherosclerosis
Vascular Disease
Arteriosclerosis
Interventions: Device: Lutonix Catheter
Device: Standard uncoated Balloon Angioplasty Catheter

  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
Lutonix DCB Catheter Lutonix DCB: Paclitaxel Coated Balloon Catheter
Uncoated PTA Balloon Catheter Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter

Participant Flow:   Overall Study
    Lutonix DCB Catheter     Uncoated PTA Balloon Catheter  
STARTED     49     52  
COMPLETED     41     38  
NOT COMPLETED     8     14  
Death                 4                 5  
Withdrawal by Subject                 2                 5  
Lost to Follow-up                 2                 4  



  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
Lutonix Catheter

Paclitaxel coated Balloon Catheter

Lutonix Catheter: Paclitaxel Coated Balloon Catheter

Standard Uncoated Balloon Angioplasty Catheter

uncoated angioplasty balloon

Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter

Total Total of all reporting groups

Baseline Measures
    Lutonix Catheter     Standard Uncoated Balloon Angioplasty Catheter     Total  
Number of Participants  
[units: participants]
  49     52     101  
Age  
[units: years]
Mean (Standard Deviation)
  67  (8)     70  (10)     68  (9)  
Gender  
[units: participants]
     
Female     15     22     37  
Male     34     30     64  
Lesion location  
[units: participants]
     
SFA     45     49     94  
Popliteal     4     3     7  
Lesion Length  
[units: mm]
Mean (Standard Deviation)
  81  (37)     80  (38)     81  (38)  
Lesion totally occluded  
[units: participants]
     
Yes     20     22     42  
    29     30     59  
Rutherford Class  
[units: participants]
     
2 (Moderate claudication)     11     11     22  
3 (Severe claudication)     35     37     72  
4 (Ischemia rest pain)     1     2     3  
5 (Minor tissue loss)     2     2     4  



  Outcome Measures
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1.  Primary:   Angiographic Late Lumen Loss   [ Time Frame: 6 months ]

2.  Secondary:   Safety - Device Related Adverse Events   [ Time Frame: 30 days ]

3.  Secondary:   Primary Patency of Treated Segment   [ Time Frame: 6, 12, 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Target Lesion Revascularization   [ Time Frame: 6, 12, 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Target Vessel Revascularization   [ Time Frame: 6, 12, 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Device Success   [ Time Frame: at procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Procedural Success   [ Time Frame: at procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change in Ankle-brachial Index   [ Time Frame: pre-procedure, 6, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Change in Walking Impairment Questionnaire (WIQ)   [ Time Frame: pre-procedure, 6, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Change in Rutherford Grade   [ Time Frame: pre-procedure,6, 12 and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Serum Paclitaxel Levels - in Subsets of Patients   [ Time Frame: 0, 1, 3 hours and pre-discharge ]
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
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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 less than or equal to 60 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: Chris Barry
Organization: Lutonix Inc. a subsidiary of C.R. Bard
phone: 763-445-2352
e-mail: LutonixResearch@crbard.com


Publications:
Publications automatically indexed to this study:

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00930813     History of Changes
Other Study ID Numbers: CL0012-01
Study First Received: June 30, 2009
Results First Received: August 5, 2014
Last Updated: November 17, 2015
Health Authority: Germany: Ethics Commission