Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)
Phase: NA
Conditions: Stenosis, Restenosis
Sponsor: C. R. Bard

*NCT Number added post-approval per CT.gov requirement
*

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COVERATM  Vascular Covered Stent 
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1 PROTOCOL SUMMARY 
Title: 
Prospective, Multi-Center Clinical Study of the COVERATM Arteriovenous (AV) Stent 
Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits 
Sponsor: 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281 
Objective: 
The objective of this study is to assess the safety and effectiveness of the COVERATM 
Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein 
anastomosis of hemodialysis patients dialyzing with a synthetic AV graft. 
Design & Overview: 
This is a prospective, multi-center, non-randomized, single-arm clinical study designed 
to assess the safety and effectiveness of the COVERATM Vascular Covered Stent for the 
treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis subjects 
with a synthetic AV graft. Safety and effectiveness measures of subjects receiving the 
COVERATM Vascular Covered Stent will be compared to Performance Goals (PG) 
derived from the results reported in clinical literature as well as those of other 
prospective pivotal and post-market studies. 
Follow-up for all treated subjects will be performed at hospital discharge, 30 and 90 
days, as well as 6, 12, 18, and 24 months post-index procedure.  
Study Device: 
The COVERATM Vascular Covered Stent is a highly flexible self-expanding 
endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating 
a nitinol (nickel-titanium alloy) stent framework. The inner lumen of the stent graft 
(blood contacting surface) is carbon impregnated. 
The COVERATM Vascular Covered Stent is available in a straight and a flared 
configuration. Devices will come on either an 8F or 9F system. 
Table 1: COVERATM Vascular Covered Stent Sizes 
 
Covered Stent Length (mm) 
Endovascular 
System 
Length (cm) 
30* 
40 
60 
80 
100 
Covered Stent Outer 
Diameter (mm) 
6 
 
 
 
 
 
80 and 120 
7 
 
 
 
 
 
8 
 
 
 
 
 
9 
 
 
 
 
 
10 
 
 
 
 
 
* Note: only the straight configuration of the implant is available in 30mm length. 
Enrollment: 
Enrollment will continue until a total of one-hundred nine (109) subjects are treated 
with the COVERATM Vascular Covered Stent. All subjects will be followed for 24 
months post index procedure. 
Investigational 
Sites: 
Up to 30 investigational sites in the United States (US). 
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 synthetic 
AV access graft with a hemodynamically significant stenosis at the graft-vein 
anastomosis. 

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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 a synthetic AV access graft located in an arm that has been 
implanted for  30 days and must have undergone at least one successful dialysis 
session prior to the index procedure.  
Angiographic Inclusion Criteria 
5. 
Subject must have angiographic evidence of a stenosis ≥ 50% (by visual 
estimation) located at the graft-vein anastomosis of the subject’s synthetic AV 
access graft and present with clinical evidence of graft dysfunction at the 
synthetic AV graft-vein anastomosis. 
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 vessel must be 
between 5.0 and 9.0mm. 
Exclusion Criteria: 
Clinical Exclusion Criteria 
1. 
The subject is dialyzing with an AV fistula. 
2. 
The hemodialysis access is located in the lower extremity.  
3. 
The subject has an infected AV access graft or uncontrolled systemic infection. 
4. 
The subject has a known uncontrolled blood coagulation/bleeding disorder. 
5. 
The subject has a known allergy or hypersensitivity to contrast media which 
cannot be adequately pre-medicated. 
6. 
The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum. 
7. 
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. 
8. 
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 
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 
9. 
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. 
10. An aneurysm or pseudoaneurysm is present within the target lesion. 
11. The location of the target lesion would require the COVERATM Vascular Covered 
Stent be deployed across the elbow joint. 
12. The target lesion is located within a stent or stent graft. 
13. 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. 
14. There is incomplete expansion of an appropriately-sized angioplasty balloon to its 

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expected profile, in the operator’s judgment, during primary angioplasty at the 
target lesion prior to implantation of the study device. 
Procedures: 
All subjects will undergo a clinical evaluation at screening (prior to index procedure); 
treated subjects will 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.   
Primary Endpoints: 
The primary effectiveness endpoint of the study is an effectiveness measure based on 
Target Lesion Primary Patency (TLPP) through 6-months post index procedure. The 
primary effectiveness endpoint will be evaluated against a performance goal (PG) of 
40%. 
The primary safety endpoint is a safety measure based on safety through 30 days post 
index procedure. The primary safety endpoint will be evaluated against a PG of 88%. 
Secondary 
Endpoints: 
Secondary Endpoints without Hypothesis Testing 
 
TLPP through 30 days, 90 days, 12 months, 18 months, and 24 months. 
 
Access Circuit Primary Patency (ACPP) through 30 days, 90 days, 6 months 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 
months, and 24 months. 
 
Acute Technical Success.  
 
Acute Procedure Success (Anatomic and Clinical Success).  
Lead Principal 
Investigator: 
Bart Dolmatch, M.D. 
Interventional Radiology 
The Palo Alto Medical Foundation 
701 E. El Camino Real, 3rd Floor 
Mountain View, CA 94040 
Telephone: (650) 404-8446 
 
 

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2  STATISTICAL ANALYSIS PLAN 
2.1 Overview of Study Design 
The clinical study will be a prospective, multi-center, non-randomized, single-arm study 
with the primary objective to demonstrate the effectiveness and safety of the COVERATM 
Vascular Covered Stent for treatment of lesions at the graft-vein anastomosis of patient’s 
dialyzing with synthetic AV grafts.  
2.2 Analysis populations 
The analysis populations will be defined as follows for this study: 
 The ITT population will consist of all subjects that have met all eligibility criteria, 
undergone successful PTA of the target lesion, and into which the COVERATM 
Vascular Covered Stent System is introduced (i.e. the delivery system enters the 
subject’s body). 
Subjects who do not receive the study device, but into which the COVERATM Vascular 
Covered Stent System was introduced, will be included in the ITT population.  
Subjects who require additional treatment modalities will be included in the ITT 
population. 
 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). 
 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. Key safety analysis will be performed based on ITT population as well. 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.   
2.3 Assessment of the Poolability of Investigational Sites 
The sites will be tested for potential differences in the primary endpoints.  Sites with 
fewer than 10 treated subjects may be combined for this purpose.  The sites with less than 
10 subjects will be sorted by site number and pooled by order to form one or more 
combined site(s) with at least 10 treated subjects.  A logistic regression analysis will be 
performed with sites as a fixed effect.  If the p-value associated with the site effect is 
<0.15, it will be considered as evidence of statistical significance. Additional analyses 

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will be performed to explore the differences between sites to assess their potential causes 
and whether or not they are clinically meaningful. 
2.4 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. 
As a sensitivity analysis, the primary effectiveness and safety endpoints 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.  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 study intervention, 
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 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.  
2.5 Sample Size Estimation  
The sample size calculation assumes the following: 
1) Primary Effectiveness Endpoint – TLPP at 6 months performance goal. 
 Assumptions: 
o The COVERATM Vascular Covered Stent composite freedom from event rate is 
estimated at 55%; 
o The PG is set at 40%; 
o Attrition (drop-out) rate (by 6 months) = 15%; 
o The Type 1 error,  = 0.05 (one-sided); and 
o The Type 2 error,  = 0.10 (Power = 1 -  = 90%). 
 Sample Size: 
o 109 treated subjects [93 evaluable] will give 90% power with one-sided type I 
error =0.05. 
2) Primary Safety Endpoint – Safety at 30 days:  
 Assumptions: 
o The primary safety rate through 30 days in the study device treated subjects is 
98%; 
o The PG is set at 88%; 

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o Attrition rate (by day 30) = 5%; and 
o The Type 1 error, α = 0.05 (one-sided). 
 Sample Size: 
o 109 treated subjects [104 evaluable] will give 99% power with one-sided type 
I error =0.05. 
Hence, the sample size of 109 subjects will provide approximately (99%)*(90%)=89% 
power for the both primary effectiveness and primary safety endpoint. 
2.6 Primary Endpoints  
2.6.1 Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the study is an effectiveness measure based 
on Target Lesion Primary Patency (TLPP) through 6-months post index procedure. 
2.6.2 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 greater 
than the effectiveness PG.   
The primary effectiveness endpoint will be evaluated by the following hypothesis: 
H0: The proportion of subjects in the study device treatment group (PCE) with 
TLPP through 6 month post index procedure is less than or equal to that of 
the effectiveness PG of 40%. 
H1: The proportion of subjects in the study device treatment group (PCE) with 
TLPP through 6 month post index procedure is greater than that of the 
effectiveness PG of 40%. 
That is: 
H0: PCE ≤ 40%,  
H1: PCE > 40%,  
Rejection of the null hypothesis will signify that the 6 month TLPP of the 
COVERATM Vascular Covered Stent is greater than the effectiveness PG of 40%.   
A one sided p-value will be derived based on an exact binomial test.  The study 
device will be considered to have achieved the primary effectiveness objective if 
the one-sided p-value is less than 0.05.  Or equivalently, the lower limit of the one-
sided 95% confidence limit based on exact method is greater than 40%.  

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2.6.3 Primary Safety Endpoint 
The primary safety endpoint is a safety measure based on safety through 30 days 
post index procedure. 
2.6.4 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 greater than the safety PG: 
H0: The proportion of subjects in the study device treatment group (PCS) free 
from safety events in the primary safety endpoint is less than or equal to 
the safety PG of 88%. 
H1: The proportion of subjects in the study device treatment group (PCS) free 
from safety events in the primary safety endpoint is greater that of the 
safety PG of 88%. 
That is: 
H0: PCS ≤ 88%,  
H1: PCS > 88%,  
Rejection of the null hypothesis will signify that the 30 day safety of the COVERATM 
Vascular Covered Stent is greater than the safety PG of 88%.   
A one sided p-value will be derived based on an exact binomial test.  The study 
device will be considered to have achieved the primary safety objective if the one-
sided p-value is less than 0.05.  Or equivalently, the lower limit of the one-sided 
95% confidence limit based on exact method is greater than 88%.   
2.7 Evaluation of Secondary Endpoints  
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.   
 TLPP through 30 days, 90 days, 12 months, 18 months, and 24 months. 
 ACPP through 30 days, 90 days, 6 months, 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. 

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 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).  
2.8 Exploratory Analyses and Subgroup Analyses 
The primary endpoints will be explored in subgroups: 
 Gender; 
 Geography; 
 Lesion characteristics; and 
 Presence of secondary lesion(s). 
The information is intended to be reported in the device’s labeling and will be 
summarized using descriptive statistics. 
2.9 Interim Analysis 
An interim analysis will be performed when all subjects have completed the 6-month 
follow-up visit.