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

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ClinicalTrials.gov Identifier: NCT01257438
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Restenosis
Interventions Device: Fluency Plus Endovascular Stent Graft
Device: Percutaneous Transluminal Angioplasty only
Enrollment 275
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluency PTA Only
Hide Arm/Group Description

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis
Period Title: Overall Study
Started 132 143
Completed 102 97
Not Completed 30 46
Arm/Group Title Fluency PTA Only Total
Hide Arm/Group Description

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis Total of all reporting groups
Overall Number of Baseline Participants 132 143 275
Hide Baseline Analysis Population Description
275 subjects were enrolled but, the primary effectiveness endpoint was statistically tested with 220 subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 143 participants 275 participants
62.6  (13.57) 61.1  (13.47) 61.9  (13.52)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 143 participants 275 participants
Female
64
  48.5%
70
  49.0%
134
  48.7%
Male
68
  51.5%
73
  51.0%
141
  51.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 143 participants 275 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 143 participants 275 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 132 participants 143 participants 275 participants
132
 100.0%
143
 100.0%
275
 100.0%
1.Primary Outcome
Title 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.
Hide Description Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).
Arm/Group Title Fluency PTA Only
Hide Arm/Group Description:

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis
Overall Number of Participants Analyzed 109 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects with successful ACPP
16.7
(9.24 to 24.16)
3.0
(0.00 to 6.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluency, PTA Only
Comments Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Greenwood’s estimate of variance
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.44 to 0.79
Estimation Comments [Not Specified]
2.Primary Outcome
Title Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.
Hide Description Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.
Arm/Group Title Fluency PTA Only
Hide Arm/Group Description:

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis
Overall Number of Participants Analyzed 132 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects free from safety events
96.9
(92.31 to 99.16)
96.4
(91.81 to 98.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluency, PTA Only
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Farrington and Manning Exact Test
Comments The non-inferiority margin is 0.075 (or 7.5%)
3.Secondary Outcome
Title 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.
Hide Description Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluency PTA Only
Hide Arm/Group Description:

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis
Overall Number of Participants Analyzed 109 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects with successful PLP
65.2
(55.59 to 74.86)
10.4
(4.30 to 16.57)
Time Frame all adverse events involving the AV access circuit that were reported by the Investigators from index procedure onward through 6 months, regardless of whether or not the events were classified by the Clinical Events Committee (CEC) as safety events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluency PTA Only
Hide Arm/Group Description

Fluency Plus Endovascular Stent Graft

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

PTA only: Treatment of in-stent restenosis
All-Cause Mortality
Fluency PTA Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluency PTA Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/128 (3.13%)      4/137 (2.92%)    
Blood and lymphatic system disorders     
vessel rupture * 1  0/128 (0.00%)  0 1/137 (0.73%)  1
Cardiac disorders     
ventricular fibrillation * 1  0/128 (0.00%)  0 1/137 (0.73%)  1
Infections and infestations     
Infection in the AVF venous cannulation site * 1  1/128 (0.78%)  1 1/137 (0.73%)  1
infection of the old stent in the fistula * 1  1/128 (0.78%)  1 0/137 (0.00%)  0
fever/cellulitis of both legs/sepsis * 1  1/128 (0.78%)  1 0/137 (0.00%)  0
Musculoskeletal and connective tissue disorders     
arm or hand edema * 1  2/128 (1.56%)  2 0/137 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash on arm due to allergic reaction to unknown source * 1  1/128 (0.78%)  1 1/137 (0.73%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Any Adverse Event
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluency PTA Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/128 (8.59%)      8/137 (5.84%)    
Blood and lymphatic system disorders     
Hemorrhage * 1  2/128 (1.56%)  2 0/137 (0.00%)  0
Prolonged Bleeding * 1  0/128 (0.00%)  0 1/137 (0.73%)  1
hemoptysis * 1  1/128 (0.78%)  1 0/137 (0.00%)  0
Cardiac disorders     
Ventricular Fibrillation * 1  0/128 (0.00%)  0 1/137 (0.73%)  1
Infections and infestations     
Infection * 1  2/128 (1.56%)  2 2/137 (1.46%)  2
Allergic reaction. to uncertain source; rash on right arm * 1  1/128 (0.78%)  1 0/137 (0.00%)  0
Fever/cellulitis of both legs/sepsis * 1  1/128 (0.78%)  1 0/137 (0.00%)  0
Injury, poisoning and procedural complications     
Pain * 1  0/128 (0.00%)  0 1/137 (0.73%)  1
Musculoskeletal and connective tissue disorders     
Arm or Hand Edema * 1  2/128 (1.56%)  2 0/137 (0.00%)  0
Vascular disorders     
Pseudoaneurysm * 1  2/128 (1.56%)  2 0/137 (0.00%)  0
Vessel Rupture * 1  0/128 (0.00%)  0 2/137 (1.46%)  2
Infolded covered stent  0/128 (0.00%)  0 1/137 (0.73%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Any Adverse Event
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.
 
Results Point of Contact
Name/Title: Josh Smale, Associate Director Clinical Affairs
Organization: Bard Peripheral Vascular
Phone: (480) 603-8140
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01257438     History of Changes
Other Study ID Numbers: BPV-08-002
First Submitted: December 8, 2010
First Posted: December 9, 2010
Results First Submitted: July 22, 2015
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017