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Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft (AVeNEW)

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.
 
ClinicalTrials.gov Identifier: NCT02649946
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Results First Posted : May 13, 2019
Last Update Posted : June 11, 2020
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
Conditions Stenosis
Restenosis
Interventions Device: Covera Vascular Covered Stent following PTA
Procedure: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
Enrollment 280
Recruitment Details Between June 9, 2016, and July 20, 2017, Investigators randomized 280 subjects into the study at 24 sites in the US, Europe, and Australia/New Zealand (50-75% of subjects treated in the US). The final subject completed 6 month follow-up on January 30, 2018. Anticipated data of study completion (last subject, last visit) is Q3, 2019.
Pre-assignment Details  
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Period Title: Overall Study
Started 142 138
Completed 130 123
Not Completed 12 15
Reason Not Completed
Withdrawal by Subject             1             1
Death             7             9
Physician Decision             1             0
Lost to Follow-up             2             1
Erroneously enrolled             1             0
Missed 6-month follow-up visit             0             4
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon Total
Hide Arm/Group Description

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Total of all reporting groups
Overall Number of Baseline Participants 142 138 280
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
< 65 years
79
  55.6%
76
  55.1%
155
  55.4%
≥ 65 and < 75 years
36
  25.4%
45
  32.6%
81
  28.9%
≥ 75 years
27
  19.0%
17
  12.3%
44
  15.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Female
53
  37.3%
54
  39.1%
107
  38.2%
Male
89
  62.7%
84
  60.9%
173
  61.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Hispanic or Latino
48
  33.8%
54
  39.1%
102
  36.4%
Not Hispanic or Latino
93
  65.5%
84
  60.9%
177
  63.2%
Unknown or Not Reported
1
   0.7%
0
   0.0%
1
   0.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Asian
0
   0.0%
6
   4.3%
6
   2.1%
Black or African American
36
  25.4%
36
  26.1%
72
  25.7%
Native Hawaiian or Other Pacific Island
2
   1.4%
0
   0.0%
2
   0.7%
White
100
  70.4%
92
  66.7%
192
  68.6%
Other
4
   2.8%
4
   2.9%
8
   2.9%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
United States
131
  92.3%
131
  94.9%
262
  93.6%
Europe
7
   4.9%
3
   2.2%
10
   3.6%
Australia
4
   2.8%
4
   2.9%
8
   2.9%
[1]
Measure Description: Please note that New Zealand sites are included in the Australia section.
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Diabetes (Type 1 and 2)
108
  76.1%
103
  74.6%
211
  75.4%
Dyslipidemia
95
  66.9%
85
  61.6%
180
  64.3%
Hypertension
139
  97.9%
133
  96.4%
272
  97.1%
Cigarette Smoking (current or former)
62
  43.7%
62
  44.9%
124
  44.3%
Cardiovascular Disease
95
  66.9%
95
  68.8%
190
  67.9%
Other Disease
129
  90.8%
129
  93.5%
258
  92.1%
[1]
Measure Description: Medical history information, including medical risk factors as well as selected medical history background for the ITT population is provided. "Other Disease" category includes Bleeding Disorder, Cancer, Steal Syndrome, and other.
AV Access Circuit Description: Target Limb  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Left Arm
106
  74.6%
110
  79.7%
216
  77.1%
Right Arm
36
  25.4%
28
  20.3%
64
  22.9%
AV Access Circuit Description: Access Position  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Forearm
9
   6.3%
8
   5.8%
17
   6.1%
Upper Arm
132
  93.0%
130
  94.2%
262
  93.6%
At Elbow
1
   0.7%
0
   0.0%
1
   0.4%
AV Access Circuit Description:Inflow Artery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Axillary
2
   1.4%
2
   1.4%
4
   1.4%
Brachial
128
  90.1%
127
  92.0%
255
  91.1%
Radial
12
   8.5%
9
   6.5%
21
   7.5%
AV Access Circuit Description: Outflow Vein  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Axillary
2
   1.4%
1
   0.7%
3
   1.1%
Basilic
35
  24.6%
42
  30.4%
77
  27.5%
Cephalic
105
  73.9%
95
  68.8%
200
  71.4%
AV Access Circuit Description: Fistula Configuration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Radiocephalic
12
   8.5%
9
   6.5%
21
   7.5%
Brachiocephalic
84
  59.2%
78
  56.5%
162
  57.9%
Transposed Brachiobasilic
27
  19.0%
37
  26.8%
64
  22.9%
All Other
19
  13.4%
14
  10.1%
33
  11.8%
AV Access Circuit Description: Transposed  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 138 participants 280 participants
Yes
36
  25.4%
43
  31.2%
79
  28.2%
No
106
  74.6%
95
  68.8%
201
  71.8%
1.Primary Outcome
Title Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
Hide Description TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Time Frame 6 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Target Lesion Primary Patency. Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 134 117
Measure Type: Count of Participants
Unit of Measure: Participants
105
  78.4%
55
  47.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTA Only Using Uncoated PTA Balloon
Comments

Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.

Sample size calculation: 238 randomized subjects [214 evaluable] will give 92% power with one-sided type 1 error = 0.025.

Type of Statistical Test Superiority
Comments TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.
Statistical Test of Hypothesis P-Value <0.001
Comments Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
Hide Description Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
Time Frame 30 days post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Free from Primary Safety Events. All Intended to Treat Subjects (ITT) are included in this analysis. Primary safety endpoint evaluated against standard PTA alone.2 subjects excluded from N COVERA due to discontinuation or death prior to day 23 of follow up. One subject excluded from N PTA arm due to death prior to follow up.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 137
Measure Type: Count of Participants
Unit of Measure: Participants
133
  95.0%
132
  96.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PTA Only Using Uncoated PTA Balloon
Comments

Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.

Sample size: 238 randomized subjects [226 evaluable] will give 85% power with one-sided type 1 error = 0.025.

Type of Statistical Test Non-Inferiority
Comments Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Farrington and Manning
Comments Non-inferiority test with non-inferiority margin of 10%.
3.Secondary Outcome
Title Endpoint With Hypothesis Testing: Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
Hide Description TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. Not all TLPP 12-month data were available at the time of writing the interim analysis report, therefore, the results for this outcome measure will be presented when the final study report is completed.
Time Frame 12 months post-index procedure
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP).
Hide Description

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. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis.

Testing of this secondary endpoint is performed in a hierarchical fashion.Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.Since not all TLPP at 12-month results were available at time of interim CSR report, results of ACPP at 6-month will be presented when the final report for the study is completed.

Time Frame 6 months post index procedure
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)
Hide Description

Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.

mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure although at the time of this reporting, only the 1 and 3 months data was available.

Secondary endpoints without formal hypothesis testing are limited to descriptive statistics and are presented, for this outcome, at 1 and 3 months follow-up.

Time Frame 1 and 3 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days or 90 days follow-up or did not meet endpoint inclusion criteria.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 125
Measure Type: Count of Participants
Unit of Measure: Participants
TLPP at 30-days Follow-up Number Analyzed 140 participants 125 participants
136
  97.1%
122
  97.6%
TLPP at 90-days Follow-up Number Analyzed 138 participants 121 participants
125
  90.6%
98
  81.0%
6.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)
Hide Description

ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.

N = number of subjects in the mITT Population with evaluable data.

Evaluation through 1, 3, 12, 18 and 24 months post index procedure although at the time of reporting to CT.gov, only the 1 and 3 months data was available.

Time Frame 1, 3, 12, 18, and 24 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants with ACPP by Follow-up Period (mITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days and 90 days follow-up or did not meet endpoint inclusion criteria.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 125
Measure Type: Count of Participants
Unit of Measure: Participants
ACPP at 30-days Follow-up Number Analyzed 140 participants 125 participants
133
  95.0%
120
  96.0%
ACPP at 90-days Follow-up Number Analyzed 138 participants 121 participants
110
  79.7%
95
  78.5%
7.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
Hide Description

Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population).

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

The relationships with device/procedure of the events are based on CEC adjudications.

Evaluation through 1, 3, 6, 12, 18 and 24 months post index procedure although at the time of reporting, only the 1, 3 and 6 months data was available.

Time Frame Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description

Number of Participants Free from Device and Procedure (DP) Related AEs Involving the AV Access Circuit (ITT subjects).

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 137
Measure Type: Count of Participants
Unit of Measure: Participants
DP AEs Free at 30 days Follow-up Number Analyzed 140 participants 137 participants
127
  90.7%
132
  96.4%
DP AEs Free at 90 days Follow-up Number Analyzed 138 participants 133 participants
124
  89.9%
127
  95.5%
DP AEs Free at 6 months Follow-up Number Analyzed 134 participants 129 participants
118
  88.1%
123
  95.3%
8.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Hide Description

Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion.

Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.

MITT results are presented for this analysis.

Time Frame 1, 3, 6, 12, 18 and 24 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description

The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.

The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Access Circuit Reintervention -mITT subjects

Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 69 71
Measure Type: Number
Unit of Measure: AV Access Circuit Reinterventions
AV Access Circuit Reinterventions at 30-days Number Analyzed 7 participants 6 participants
7 6
AV Access Circuit Reinterventions at 90 days Number Analyzed 30 participants 27 participants
35 34
AV Access Circuit Reinterventions at 6 months Number Analyzed 69 participants 71 participants
103 107
9.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions
Hide Description

Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects).

Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, this preliminary results report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.

Time Frame 1, 3, 6, 12, 18 and 24 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description

The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.

The total number of Target Lesion Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention.

Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 31 66
Measure Type: Number
Unit of Measure: Target Lesion Reinterventions
Target Lesion Reinterventions at 30 days Follow-up Number Analyzed 5 participants 3 participants
5 3
Target Lesion Reinterventions at 90 days Follow-up Number Analyzed 13 participants 22 participants
16 24
Target Lesion Reinterventions 6 months Follow-up Number Analyzed 31 participants 66 participants
40 92
10.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)
Hide Description

IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one.

Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the preliminary report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.

The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.

mITT results are analyzed.

Time Frame 1, 3, 6, 12, 18 and 24 months post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description

Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

mITT subjects results are presented.

Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
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Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 125
Mean (Standard Deviation)
Unit of Measure: Days
Index of Patency at 30 days Follow-up Number Analyzed 140 participants 125 participants
29.22  (3.420) 29.28  (3.219)
Index of Patency at 90 days Follow-up Number Analyzed 138 participants 121 participants
79.41  (20.511) 78.98  (20.770)
Index of Patency at 6 months Follow-up Number Analyzed 134 participants 117 participants
126.06  (54.449) 116.11  (53.175)
11.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)
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IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.

Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12, 18 and 24 months results will be provided in the final reporting for the study.

The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.

Time Frame 1, 3, 6, 12, 18 and 24 months post index procedure
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Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.

mITT subjects results are presented.

Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 125
Mean (Standard Deviation)
Unit of Measure: Days
IPTF-T at 30 days Follow-Up Number Analyzed 140 participants 125 participants
29.44  (2.958) 29.64  (2.305)
IPTF-T at 90 days Follow-Up Number Analyzed 137 participants 120 participants
85.15  (15.349) 81.35  (18.243)
IPTF-T at 6 months Follow-Up Number Analyzed 133 participants 116 participants
156.32  (43.724) 121.75  (51.940)
12.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency
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Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency.

Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.

mITT subjects results are presented.

Time Frame 1, 3, 6, 12, 18 and 24 months post index procedure
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Post-Intervention Secondary Patency by Follow-Up Period (mITT Subjects). (n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 125
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Secondary Patency at 30 days Number Analyzed 140 participants 125 participants
139
  99.3%
125
 100.0%
Participants with Secondary Patency at 90 days Number Analyzed 138 participants 120 participants
136
  98.6%
119
  99.2%
Participants with Secondary Patency at 6 months Number Analyzed 134 participants 115 participants
131
  97.8%
113
  98.3%
13.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants withTechnical Success (for Stent Graft Placement)
Hide Description

Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure. Therefore, for this measure, only COVERA data are relevant.

mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.

Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant.

Time Frame On Day of Index Procedure
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Hide Analysis Population Description
Number of Participants with Acute Technical Success (mITT Subjects). Please note that "Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure." Therefore, for this measure, only COVERA data are relevant.
Arm/Group Title Covera Vascular Covered Stent Following PTA
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Overall Number of Participants Analyzed 140
Measure Type: Count of Participants
Unit of Measure: Participants
140
 100.0%
14.Secondary Outcome
Title Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success
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Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.

Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant.

Time Frame On Day of Index Procedure
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Hide Analysis Population Description
Procedure Success (mITT Subjects). Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description:

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

Overall Number of Participants Analyzed 140 126
Measure Type: Count of Participants
Unit of Measure: Participants
138
  98.6%
124
  98.4%
Time Frame Data provided for Adverse Events (AEs) and Serious Adverse Events (SAEs) at 6-Month Follow-Up Period (ITT Subjects). All subjects underwent a clinical evaluation at the index procedure: treated subjects also underwent a follow-up clinical evaluation prior to hospital discharge. Subsequent follow-up for all treated subjects was performed at 30 days, 90 days and 6 months. The 6 month follow up was an office visit to the investigational site in addition to a telephone call to dialysis centre.
Adverse Event Reporting Description

Both AEs and SAEs were collected based on the ITT population. SAEs results shown are CEC adjudicated.

Note that n= subjects with at least one event. AEs and SAEs that occurred through 180 days are included. AEs and SAEs in Tables below were reported in the CSR by Organ Class only, without regards to the specific Adverse Event Terms.

 
Arm/Group Title Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Hide Arm/Group Description

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Covera Vascular Covered Stent following PTA: Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon: Treatment of stenoses with PTA only

All-Cause Mortality
Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Affected / at Risk (%) Affected / at Risk (%)
Total   6/142 (4.23%)      9/138 (6.52%)    
Hide Serious Adverse Events
Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/142 (40.14%)      43/138 (31.16%)    
Blood and lymphatic system disorders     
Blood and lymphatic  1  2/142 (1.41%)  2 1/138 (0.72%)  1
Cardiac disorders     
Cardiac disorders  1  10/142 (7.04%)  10 12/138 (8.70%)  12
Eye disorders     
Eye disorders  1  1/142 (0.70%)  1 0/138 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal  1  9/142 (6.34%)  9 6/138 (4.35%)  6
General disorders     
General disorders and administration site conditions  1  5/142 (3.52%)  5 0/138 (0.00%)  0
Infections and infestations     
Infections and Infestations  1  19/142 (13.38%)  19 17/138 (12.32%)  17
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  14/142 (9.86%)  14 5/138 (3.62%)  5
Investigations     
Investigations  1  0/142 (0.00%)  0 0/138 (0.00%)  0
Metabolism and nutrition disorders     
Metabolism and nutrition  1  12/142 (8.45%)  12 6/138 (4.35%)  6
Musculoskeletal and connective tissue disorders     
Muskuloskeletal and connective disorders  1  2/142 (1.41%)  2 0/138 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1  0/142 (0.00%)  0 1/138 (0.72%)  1
Nervous system disorders     
Nervous system  1  3/142 (2.11%)  3 4/138 (2.90%)  4
Psychiatric disorders     
Psychiatric  1  0/142 (0.00%)  0 1/138 (0.72%)  1
Renal and urinary disorders     
Renal and urinary  1  1/142 (0.70%)  1 3/138 (2.17%)  3
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal  1  7/142 (4.93%)  7 3/138 (2.17%)  3
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue  1  0/142 (0.00%)  0 1/138 (0.72%)  1
Vascular disorders     
Vascular  1  12/142 (8.45%)  12 10/138 (7.25%)  10
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Covera Vascular Covered Stent Following PTA PTA Only Using Uncoated PTA Balloon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/142 (55.63%)      64/138 (46.38%)    
Blood and lymphatic system disorders     
Blood and lymphatic  1  3/142 (2.11%)  3 3/138 (2.17%)  3
Cardiac disorders     
Cardiac  1  14/142 (9.86%)  14 15/138 (10.87%)  15
Ear and labyrinth disorders     
Ear and labyrinth  1  2/142 (1.41%)  2 0/138 (0.00%)  0
Endocrine disorders     
Endocrine  1  0/142 (0.00%)  0 3/138 (2.17%)  3
Eye disorders     
Eye  1  1/142 (0.70%)  1 0/138 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal  1  12/142 (8.45%)  12 10/138 (7.25%)  10
General disorders     
General disorders  1  10/142 (7.04%)  10 2/138 (1.45%)  2
Hepatobiliary disorders     
Hepatobiliary  1  1/142 (0.70%)  1 1/138 (0.72%)  1
Immune system disorders     
Immune system  1  0/142 (0.00%)  0 1/138 (0.72%)  1
Infections and infestations     
Infections and Infestations  1  27/142 (19.01%)  27 24/138 (17.39%)  24
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  24/142 (16.90%)  24 14/138 (10.14%)  14
Investigations     
Investigations  1 [1]  2/142 (1.41%)  2 2/138 (1.45%)  2
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  14/142 (9.86%)  14 11/138 (7.97%)  11
Musculoskeletal and connective tissue disorders     
Muskuloskeletal and connective tissues  1  8/142 (5.63%)  8 5/138 (3.62%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm benign, malignant and unspecified  1  1/142 (0.70%)  1 1/138 (0.72%)  1
Nervous system disorders     
Nervous system disorders  1  6/142 (4.23%)  6 7/138 (5.07%)  7
Psychiatric disorders     
Psychiatric  1  1/142 (0.70%)  1 2/138 (1.45%)  2
Renal and urinary disorders     
Renal and urinary  1  3/142 (2.11%)  3 3/138 (2.17%)  3
Reproductive system and breast disorders     
Reproductive system and breast  1  1/142 (0.70%)  1 0/138 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal  1  8/142 (5.63%)  8 9/138 (6.52%)  9
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue  1  0/142 (0.00%)  0 3/138 (2.17%)  3
Vascular disorders     
Vascular  1  17/142 (11.97%)  17 15/138 (10.87%)  15
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
[1]
Electrocardiogram ST segment depression, liver function, abnormal and test abnormal, peritoneal effluent and troponin T increase.
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.
Prior to PI publication of site results, sponsor requires publication of multi-centers results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Talar Saber, Senior Project Manager, Clinical Affairs
Organization: BD/Bard
Phone: (480) 379-2839
EMail: Talar.Saber@crbard.com
Layout table for additonal information
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02649946    
Other Study ID Numbers: BPV-14-005
First Submitted: January 4, 2016
First Posted: January 8, 2016
Results First Submitted: March 15, 2019
Results First Posted: May 13, 2019
Last Update Posted: June 11, 2020