FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis (RESCUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01257438
First received: December 8, 2010
Last updated: November 9, 2016
Last verified: November 2016
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Restenosis
Interventions: Device: Fluency Plus Endovascular Stent Graft
Device: Percutaneous Transluminal Angioplasty only

  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
Fluency

Fluency Plus Endovascular Stent Graft

Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis

PTA Only PTA only: Treatment of in-stent restenosis

Participant Flow:   Overall Study
    Fluency   PTA Only
STARTED   132   143 
COMPLETED   102   97 
NOT COMPLETED   30   46 



  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.
275 subjects were enrolled but, the primary effectiveness endpoint was statistically tested with 220 subjects.

Reporting Groups
  Description
Fluency

Fluency Plus Endovascular Stent Graft

Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis

PTA Only PTA only: Treatment of in-stent restenosis
Total Total of all reporting groups

Baseline Measures
   Fluency   PTA Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   143   275 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (13.57)   61.1  (13.47)   61.9  (13.52) 
Gender 
[Units: Participants]
Count of Participants
     
Female      64  48.5%      70  49.0%      134  48.7% 
Male      68  51.5%      73  51.0%      141  51.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      21  15.9%      18  12.6%      39  14.2% 
Not Hispanic or Latino      111  84.1%      125  87.4%      236  85.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      4   2.8%      4   1.5% 
Asian      1   0.8%      1   0.7%      2   0.7% 
Native Hawaiian or Other Pacific Islander      1   0.8%      2   1.4%      3   1.1% 
Black or African American      72  54.5%      84  58.7%      156  56.7% 
White      57  43.2%      50  35.0%      107  38.9% 
More than one race      1   0.8%      2   1.4%      3   1.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   132   143   275 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.   [ Time Frame: 6 months ]

2.  Primary:   Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.   [ Time Frame: 30 days ]

3.  Secondary:   Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.   [ Time Frame: 6 months ]


  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 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: Josh Smale, Associate Director Clinical Affairs
Organization: Bard Peripheral Vascular
phone: (480) 603-8140
e-mail: Josh.Smale@crbard.com



Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01257438     History of Changes
Other Study ID Numbers: BPV-08-002
Study First Received: December 8, 2010
Results First Received: July 22, 2015
Last Updated: November 9, 2016