A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
Phase: NA
Conditions: Stenosis, Restenosis
Sponsor: C. R. Bard



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Enrollment: 
A total of 280 subjects will be randomized to the study. The primary endpoint analysis 
will occur when 280 randomized subjects have completed or discontinued before their 
6 month follow up.  The key secondary endpoint analysis will occur when 280 
randomized subjects have completed or discontinued before their 12 month follow up.  
All subjects will be followed for 24 months post index-procedure. 
Investigational 
Sites: 
Up to 35 investigational sites in the United States (US), Europe, and Australia/New 
Zealand will participate. Treated subjects will be distributed globally with 50-75% of 
the treated subjects in the U.S. 
Study Population: 
Male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to 
allow for completion of all study procedures. Eligible subjects will have a 
hemodynamically significant stenosis. 
Inclusion Criteria 
Clinical Inclusion Criteria 
1. 
Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to 
collection of study data or performance of study procedures. 
2. 
Subject must be either a male or non-pregnant female ≥ 21 years of age with an 
expected lifespan sufficient to allow for completion of all study procedures. 
3. 
Subject must be willing to comply with the protocol requirements, including 
clinical and telephone follow-up. 
4. 
Subject must have an upper extremity AV fistula that has undergone at least one 
successful dialysis session with two-needle cannulation, prior to the index 
procedure.  
Angiographic Inclusion Criteria 
5. 
Subject must have angiographic evidence of a stenosis ≥ 50% (by visual 
estimation) located in the venous outflow of the AV access circuit and present 
with clinical or hemodynamic evidence of AV fistula dysfunction. 
6. 
The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist 
within the target lesion.  
7. 
The reference vessel diameter of the adjacent non-stenotic vein must be between 
5.0 and 9.0mm. 
Exclusion Criteria 
Clinical Exclusion Criteria 
1. 
The subject is dialyzing with an AV graft. 
2. 
The target lesion has had a corresponding thrombosis treated within 7 days prior 
to the index procedure. 
3. 
The hemodialysis access is located in the lower extremity.  
4. 
The subject has an infected AV fistula or uncontrolled systemic infection. 
5. 
The subject has a known uncontrolled blood coagulation/bleeding disorder. 
6. 
The subject has a known allergy or hypersensitivity to contrast media which 
cannot be adequately pre-medicated. 
7. 
The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum. 
8. 
The subject has another medical condition, which, in the opinion of the 
Investigator, may cause him/her to be non-compliant with the protocol, confound 
the data interpretation, or is associated with a life expectancy insufficient to allow 
for the completion of study procedures and follow-up. 
9. 
The subject is currently participating in an investigational drug or another device 
study that has not completed the study treatment or that clinically interferes with 

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the study endpoints.  Note:  Studies requiring extended follow-up visits for 
products that were investigational, but have since become commercially 
available, are not considered investigational studies. 
Angiographic Exclusion Criteria 
10. Additional stenotic lesions (≥ 50%) in the venous outflow that are > 3cm from the 
edge of the target lesion and are not successfully treated (defined as ≤ 30% 
residual stenosis) prior to treating the target lesion. 
11. An aneurysm or pseudoaneurysm is present within the target lesion. 
12. The location of the target lesion would require the COVERATM Vascular Covered 
Stent be deployed across the elbow joint. 
13. The target lesion is located within a stent. 
14. The location of the target lesion would require that the COVERATM Vascular 
Covered Stent be deployed at or across the segment of fistula utilized for dialysis 
needle puncture (i.e., “cannulation zone”). 
15. The location of the target lesion would require that the COVERATM Vascular 
Covered Stent be placed in the central veins (subclavian, brachiocephalic, 
Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet.  
16. There is incomplete expansion of an appropriately sized angioplasty balloon to its 
expected profile, in the operator’s judgment, during primary angioplasty at the 
target lesion prior to randomization. 
Procedures: 
All subjects will undergo a clinical evaluation at screening (prior to index procedure); 
treated subjects will also undergo a clinical evaluation prior to hospital discharge. A 
telephone screen to the subject and the dialysis center will be performed at all follow-
up visits.  The 6 month follow up should occur via an office visit to the investigational 
site in addition to the phone call to the dialysis center. 
Primary Endpoints 
Primary Effectiveness Endpoints with Hypothesis Testing 
• 
Target Lesion Primary Patency (TLPP) through 6 months. 
Primary Safety Endpoint with Hypothesis Testing 
• 
Safety through 30 days. 
Secondary 
Endpoints: 
Key Secondary Endpoint with Hypothesis Testing 
• 
TLPP through 12 months. 
• 
Access Circuit Primary Patency (ACPP) through 6 months. 
Secondary Endpoints without Hypothesis Testing 
• 
TLPP through 30 days, 90 days, 18 months, and 24 months. 
• 
ACPP through 30 days, 90 days, 12 months, 18 months, and 24 months. 
• 
Rate of device and procedure related AEs involving the AV access circuit 
through 90 days, 6 months, 12 months, 18 months, and 24 months. 
• 
Total Number of AV Access Circuit Reinterventions through 30 days, 90 days, 6 
months, 12 months, 18 months, and 24 months.  
• 
Total Number of Target Lesion Reinterventions through 30 days, 90 days, 6 
months, 12 months, 18 months, and 24 months. 
• 
Index of Patency Function (IPF) evaluated at 30 days, 90 days, 6 months, 12 
months, 18 months, and 24 months. 
• 
Index of Patency Function – Target Lesion (IPF-T) evaluated at 30 days, 90 days, 
6 months, 12 months, 18 months, and 24 months. 
• 
Secondary Patency evaluated through 30 days, 90 days, 6 months, 12 months, 18 

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months, and 24 months. 
• 
Acute Technical Success.  
• 
Acute Procedure Success (Anatomic and Clinical Success).  
Lead Principal 
Investigator: 
 
 
 
 
 
 
 
 
Angiographic Core 
Lab 
 
 
 
 
 

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 STATISTICAL ANALYSIS PLAN 
1.1 Overview of Study Design 
The clinical study will be a prospective, multi-center, randomized safety and 
effectiveness study with the primary objective to demonstrate superior effectiveness and 
non-inferior safety of the COVERATM Vascular Covered Stent by direct comparison to 
standard PTA alone for treatment of lesions of AV fistulas.  
For the study to be considered successful, superiority of the COVERATM Vascular Covered 
Stent must be demonstrated for the primary effectiveness endpoint, and non-inferiority of 
the COVERATM Vascular Covered Stent must be demonstrated for the primary safety 
endpoint as compared to PTA alone. 
1.2 Analysis populations 
The analysis populations will be defined as follows for this study: 
• The ITT population will consist of all enrolled subjects who have signed the ICF and 
have been randomized. 
• The Modified ITT (MITT) population will consist of any subjects in the ITT 
population who are treated with the COVERATM Vascular Covered Stent (following 
PTA) or PTA alone. 
• A Per-Protocol (PP) population may be created if there are subjects who have any 
major protocol deviations. The PP population will consist of any subjects in the MITT 
population who do not have any major protocol deviation. The protocol deviations 
that are considered to have a “major” grade will be defined a priori in the analysis 
plan. 
All analyses including the primary analyses will be primarily based on the MITT 
population. PP analyses may also be performed for the primary endpoints. They will only 
serve as sensitivity analyses for the primary analyses which are based on the MITT 
population.  Additionally As-treated (AT) analysis may be performed in which subjects 
will be analyzed based on the actual treatment received instead of the randomized 
treatment, if there are subjects randomized but received the wrong treatment. 
1.3 Randomization 
The treatment randomization will be 1:1.   

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1.4 Assessment of the Comparability of Treatment Groups and Poolability of 
Investigational Sites 
To demonstrate the comparability of the Control to Test subjects, the treatment groups 
will be compared with respect to demographics and baseline characteristics and other 
covariates using t-tests or Wilcoxon nonparametric tests for means and X2-tests for 
proportions. 
Demographics, baseline characteristics and other covariates will also be compared 
between the treatment groups by sites using descriptive statistics. Both primary endpoints 
will also be summarized by treatment group and by site. This can help identify any 
confounding covariates that can potentially explain the variability of the treatment effect 
across sites. Sites with fewer than 10 treated subjects may be combined for this purpose.  
The pooling will be restricted within country.  
For the primary effectiveness endpoint, an analysis will be performed to examine the 
potential for interaction of site and treatment group. A Cox regression model will be fit 
that includes fixed effect for treatment group, site and the interaction of treatment group 
and site. If the p-value for the interaction term is <0.15, it will be considered evidence of 
a possible significant interaction effect, and additional analyses will be performed to 
explore the differences between sites to assess their potential causes and whether or not 
they are clinically meaningful.  
For the primary safety endpoint, an analysis will be performed as well to examine the 
potential for interaction of site and treatment group. A logistic regression model will be 
fit that includes fixed effect for treatment group, site and the interaction of treatment 
group and site. If the p-value for the interaction term is <0.15, it will be considered 
evidence of a possible significant interaction effect, and additional analyses will be 
performed to explore the differences between sites to assess their potential causes and 
whether or not they are clinically meaningful.  
Both primary endpoints will also be presented by geography (US versus OUS). Similar 
analyses will be performed to examine the potential for interaction of geography and 
treatment group for both endpoints. A Cox regression model for the primary effectiveness 
endpoint and a logistic regression model for the primary safety endpoint will be fit that 
includes fixed effect for treatment group, geography and the interaction of treatment 
group and geography. If the p-value for the interaction term is <0.15, it will be considered 
evidence of a possible significant interaction effect, and additional analyses will be 
performed to explore the differences between geographies to assess their potential causes 
and whether or not they are clinically meaningful. 

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1.5 Handling of Missing Data 
Study endpoints may be missing due to withdrawal of consent, Investigator’s decision, 
LTF and subject death.  It is important to minimize missing data by all means and always 
record the reason for missing.  Missing data will be handled as described subsequently. 
The primary analysis of the primary effectiveness endpoint is a survival analysis.  As a 
sensitivity analysis, the primary safety endpoint will also be analyzed using survival 
analysis techniques.  In survival analyses, unobserved endpoints are a standard part of the 
analysis; they are known as “censored observations”.  As long as the censoring is 
unrelated to the treatment, this method of handling missing endpoints produces unbiased 
estimates of the freedom-from-event rates. In addition, as a sensitivity analysis, the 
primary effectiveness endpoint will be analyzed as a proportion-based binomial rate.   
For both primary endpoints, the reason for the censoring of all subjects with missing 
endpoints will be reported.  If there is any indication that the censoring is related to the 
treatment group, a worst-case analysis may be performed for each primary endpoint, in 
addition to the standard analysis.  In a worst-case analysis, an event will be assumed to 
have occurred at the time the subject was censored for all such subjects in the Test group. 
In the Control group, all subjects with missing data will be assumed not to have had an 
event.  
In addition, regardless of whether missing data are related to the study intervention, a 
tipping-point analysis will also be performed, in which assumptions about missing data 
are varied from worst-case to best-case to examine at what point the missing data would 
alter the results of the analysis.  
1.6 Sample Size Estimation  
The sample size is estimated to give adequate power on the two co-primary endpoints as 
well as for the key secondary endpoint. Sample size assumptions and determinations are 
summarized subsequently. 
1) Key Secondary Endpoint – TLPP at 12 months: 
• Assumptions: 
o TLPP rate through 12 months for the study device treated subjects is 55%; 
o TLPP rate through 12 months for the PTA only treated subjects is 33%; 
o Allocation ratio: 1:1; 
o Attrition (drop-out) rate (by 12 months) = 15% 
o The Type 1 error, α = 0.025 (one-sided); and 
o The Type 2 error, β = 0.10 (Power = 1 – β = 90%). 
• Sample Size: 
o 280 randomized subjects [238 evaluable] will give 90% power with one-sided 
type I error =0.025. 

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2) Primary Effectiveness Endpoint – TLPP at 6 months: 
• Assumptions: 
o TLPP rate through 6 months for the study device treated subjects is 73%; 
o TLPP rate through 6 months for the PTA only treated subjects is 50%; 
o Allocation ratio: 1:1; 
o Attrition (drop-out) rate (by 6 months) = 10% 
o The Type 1 error, α = 0.025 (one-sided); and 
o The Type 2 error, β = 0.10 (Power = 1 – β = 95%). 
• Sample Size: 
o 280 randomized subjects [252 evaluable] will give 95% power with one-sided 
type I error =0.025. 
3) Primary Safety Endpoint – Safety at 30 days:  
• Assumptions: 
o The primary safety rate through 30 days in the study device treated subjects is 
95%; 
o The primary safety rate through 30 days in the PTA only treated subjects is 
95%; 
o Non-inferiority margin δ = 10%;  
o Allocation ratio: 1:1; 
o Attrition rate (by day 30) = 5%; and 
o The Type 1 error, α = 0.025 (one-sided). 
• Sample Size: 
o 280 randomized subjects [266 evaluable] will give 91% power with one-sided 
type I error =0.025. 
Hence, the sample size of 280 randomized subjects, allocated 1:1, for 140 subjects in the 
COVERATM Vascular Covered Stent arm and 140 subjects in the PTA alone arm, will 
provide approximately 86% power for the both primary effectiveness and primary safety 
endpoint. The sample size of 280 randomized subjects, allocated 1:1 for 140 subjects in 
the COVERATM Vascular Covered Stent arm and 140 in the PTA alone arm, will provide 
approximately 90% power for the key secondary endpoint. 
1.7 Primary Endpoints  
1.7.1 Primary Effectiveness Endpoint 
The Primary effectiveness endpoint is TLPP evaluated at 6 months (Refer to 
Section 4.1.1 for applicable definitions). In order to demonstrate clinically 
acceptable effectiveness, this randomized study will assess superiority of the rate of 
TLPP at 6 months of the COVERATM Vascular Covered Stent as compared to 
standard PTA alone.   

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1.7.2 Primary Effectiveness Endpoint Hypothesis Test 
The primary effectiveness endpoint is TLPP through 6-months.  Objective: To 
assess if the 6 month TLPP for the COVERATM Vascular Covered Stent is superior to 
that of PTA alone, by direct comparison.   
The primary effectiveness endpoint will be evaluated by the following hypothesis: 
H0: The (survival) rate S1(t) of subjects in the study device treatment group 
with TLPP through t ≤ 6 month post index procedure is less than or equal 
to that S2(t) of PTA treatment group. 
H1: The (survival) rate S1(t) of subjects in the study device treatment group 
with TLPP through t ≤ 6 month post index procedure is greater than that 
S2(t) of PTA treatment group. 
That is: 
H0: S1(t) ≤ S2(t), for t ≤ 6 months 
H1: S1(t) > S2(t), for t ≤ 6 months 
Rejection of the null hypothesis will signify that the 6 month TLPP of the COVERATM 
Vascular Covered Stent is superior to the 6 month TLPP of PTA alone.   
A Kaplan-Meier analysis will be used to estimate the survival rate of TLPP in the 
COVERATM Vascular Covered Stent and PTA alone groups.  A log-rank test will be 
used to test the primary effectiveness hypothesis to determine if COVERATM Vascular 
Covered Stent  is superior to PTA.  The test is successful if the one-sided p-value is 
less than 0.025 and the result is in favor of the COVERATM Vascular Covered Stent.  
In addition to the p-value of the test, the confidence intervals of the rate in each 
group will be provided.  
1.7.3 Primary Safety Endpoint 
The primary safety endpoint is proportion of subjects who are free from localized or 
systemic adverse events through 30 days that reasonably suggests the involvement 
of the AV access circuit (Refer to Section 4.1.2 for applicable definitions). 
1.7.4 Primary Safety Endpoint Hypothesis Test 
The primary safety endpoint is safety through 30 days.  Objective:  To assess if the 
30-day primary safety rate for the study device is non-inferior to that of PTA alone, 
by direct comparison: 

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H0: The primary safety rate p1 in the Test group through 30 days post index 
procedure is inferior to that p2 of the PTA treatment group. 
H1: The primary safety rate p1 in the Test group through 30 days post index 
procedure is non-inferior to that p2 of the PTA treatment group. 
That is: 
H0: p1 ≤ p2  - δ 
H1: p1  > p2  - δ 
Where δ = 10% is the non-inferiority margin, which is the range of difference that is 
considered not clinically important. 
Non-inferiority Farrington and Manning Exact Test will be used to test the primary 
safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. 
In addition to the p-value of the test, the confidence intervals of the rate in each 
group and the difference between the two groups will be provided.   
1.8 Evaluation of Secondary Endpoints  
All secondary endpoints will be tested as exploratory only unless both primary 
hypotheses are successful. The testing of the secondary objectives will be performed in a 
hierarchical fashion in the order in which they are listed below. This means that as soon 
as a null hypothesis is not rejected, all further hypotheses will be tested for exploratory 
purpose only. This hierarchical testing scheme ensures that the study-wide Type 1 error 
rate remains at 0.05 when all of the secondary endpoints are tested at α=0.05. 
1.8.1 Key Secondary Endpoint with Hypothesis Test: TLPP at 12 Months 
The key secondary effectiveness endpoint is TLPP through 12-months.  Objective: 
To assess if the 12 month TLPP for the COVERATM Vascular Covered Stent is 
superior to that of PTA alone, by direct comparison.   
The primary effectiveness endpoint will be evaluated by the following hypothesis: 
H0: The (survival) rate S1(t) of subjects in the study device treatment group 
with TLPP through t ≤ 12 month post index procedure is less than or equal 
to that S2(t) of PTA treatment group. 
H1: The (survival) rate S1(t) of subjects in the study device treatment group 
with TLPP through t ≤ 12 month post index procedure is greater than that 
S2(t) of PTA treatment group. 

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That is: 
H0: S1(t) ≤ S2(t), for t ≤ 12 months 
H1: S1(t) > S2(t), for t ≤ 12 months 
Rejection of the null hypothesis will signify that the 12 month TLPP of the 
COVERATM Vascular Covered Stent is superior to the 12 month TLPP of PTA alone.   
A Kaplan-Meier analysis will be used to estimate the survival rate of TLPP in the 
COVERATM Vascular Covered Stent and PTA alone groups.  A log-rank test will be 
used to test the key secondary effectiveness hypothesis to determine if the 
COVERATM Vascular Covered Stent is superior to PTA.  The test is successful if the 
one-sided p-value is less than 0.025 and the result is in favor of the COVERATM 
Vascular Covered Stent.  In addition to the p-value of the test, the confidence 
intervals of the rate in each group will be provided. Note that, unless both the 
primary endpoints are successful, hypothesis for the key secondary effectiveness 
will be tested for exploratory purpose only.  
1.8.2 Key Secondary Endpoint with Hypothesis Test: ACPP at 6 Months 
The key secondary endpoint is ACPP evaluated at 6 months (Refer to Section 4.2.1 
for applicable definitions).  Objective: To assess if the 6 months ACPP rates for the 
COVERATM Vascular Covered Stent is superior to the primary patency rate for 
standard PTA, by direct comparison: 
H0: The (survival) rate S1(t) of subjects in the study device treatment group 
with ACPP through t ≤ 6 month post index procedure is less than or equal 
to that S2(t) of PTA treatment group. 
H1:  The (survival) rate S1(t) of subjects in the study device treatment group 
with ACPP through t ≤ 6 month post index procedure is greater than that 
S2(t) of PTA treatment group. 
That is: 
H0: S1(t) ≤ S2(t), for t ≤ 6 months 
H1: S1(t) > S2(t), for t ≤ 6 months 
Rejection of the null hypothesis will signify that the 6 month ACPP of the 
COVERATM Vascular Covered Stent   is superior to the 6 month ACPP of standard 
PTA alone.   

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A Kaplan-Meier analysis will be used to estimate the survival rate of ACPP in the 
COVERATM Vascular Covered Stent and PTA alone groups.  A log-rank test will be 
used to test this hypothesis to determine if the COVERATM Vascular Covered Stent is 
superior to PTA alone.  The test is successful if the two-sided p-value is less than 
0.05 and the result is in favor of the COVERATM Vascular Covered Stent.  In addition 
to the p-value of the test, the confidence intervals of the rate in each group will be 
provided. Note that, unless both the primary endpoints, and the TLPP at 12-month 
endpoint are all successful, the hypothesis for the ACPP at 6-month will be tested 
for exploratory purpose only.  
1.8.3 Secondary Endpoints with Descriptive Statistics 
The following secondary endpoints will be summarized with descriptive statistics 
(without formal statistical hypothesis testing) using the MITT population.  For 
categorical variables, summary statistics will include frequency counts and 
percentages.  For continuous variables, summary statistics will include mean, 
standard deviation, minimum, median, and maximum. Refer to Section 4.2.2 for 
any applicable definitions.   
• TLPP through 30 days, 90 days, 18 months, and 24 months. 
• ACPP through 30 days, 90 days, 12 months, 18 months, and 24 months. 
• Rate of device and procedure related AEs involving the AV access circuit 
through 90 days, 6 months, 12 months, 18 months, and 24 months. 
• Total Number of AV Access Circuit Reinterventions through 30 days, 90 days, 
6 months, 12 months, 18 months, and 24 months.  
• Total Number of Target Lesion Reinterventions through 30 days, 90 days, 6 
months, 12 months, 18 months, and 24 months. 
• IPF evaluated at 30 days, 90 days, 6 months, 12 months, 18 months, and 24 
months follow-up. 
• IPF-T evaluated at 30 days, 90 days, 6 months, 12 months, 18 months, and 24 
months. 
• Secondary Patency evaluated through 30 days, 90 days, 6 months, 12 months, 
18 months, and 24 months. 
• Acute Technical Success.  
• Acute Procedure Success (Anatomic and Clinical Success).