The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)
Phase: NA
Conditions: May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease
Sponsor: C. R. Bard

        NCT02655887 
        *NCT number added post-approval as per CT.gov requirement
  
  
     
        NCT02655887 
        *NCT number added post-approval as per CT.gov requirement
  
  
     
        NCT02655887 
        *NCT number added post-approval as per CT.gov requirement
  
  
     
        NCT02655887 
        *NCT number added post-approval as per CT.gov requirement
      

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Clinical Protocol Summary 
 
Title:  
The BARD® VENOVO ™ Venous Stent Study -  A Prospective, Non-
Randomized, Multi-Center, Single-Arm Study of the Treatment of 
Iliofemoral Occlusive Disease – an Assessment for Effectiveness and 
Safety  (VERNACULAR) 
 
Sponsor: 
Bard Peripheral Vascular, Inc. (“Bard”) 
1625 West 3rd Street 
Tempe, Arizona 85281 USA 
Objectives: 
The objective of this study is to assess the safety and effectiveness of the  
VENOVO ™ Venous Stent for the treatment of symptomatic iliofemoral  
venous outflow obstruction.  This would include Acute or Chronic Deep 
Vein Thrombosis (DVT), May-Thurner Syndrome, or any combination of 
the above. 
Design: 
This is a prospective, multi-center, non-randomized, single-arm clinical 
study of the VENOVO ™ Venous Stent for the treatment of symptomatic 
iliofemoral venous outflow obstruction.    Safety and effectiveness 
measures of subjects receiving the VENOVO ™ Venous Stent will be 
compared to a Performance Goal (PG) derived from published literature.   
 
The study will be conducted at a maximum of 35 investigational sites 
(“sites”) in the United States, and Europe and Australia/New Zealand.   
 
Clinical follow-up for all treated subjects will be performed at hospital 
discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.  
Devices: 
The VENOVO ™ Venous Stent is comprised of a self-expanding nitinol 
(nickel-titanium) alloy. The diameter of the flared ends is approximately 
3 mm larger than the diameter of the nominal stent body and  contains 
radiopaque tantalum markers. 
Size Matrix: 
Stent 
Diameter 
(mm) 
Delivery 
System 
Profile 
 
Stent Length (mm) 
10 
 
8 Fr 
 
 
 
 
 
 
 
12 
 
 
 
 
 
 
 
14 
9 Fr 
40 
60 
80 
100 
120 
140 
160 
16 
 
10 Fr 
 
 
 
 
 
 
 
18 
 
 
 
 
 
 
 
20 
 
 
 
 
 
 
 
 
 
Enrollment: 
Bard plans for enrollment to continue until a maximum of one-hundred 
seventy (170) subjects are treated with the VENOVO ™ Venous Stent 
which is an estimated three hundred forty (340) consecutive subjects in a 
non-randomized fashion. 
 Subjects will be considered enrolled in the study at the time the informed 
consent document is signed (an estimated 340 subjects). After the subject 
has met all eligibility criteria and the VENOVO ™ Venous Stent catheter 

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is introduced (i.e. delivery system enters the subject’s body), the subject 
will enter the primary analysis population (up to 170 subjects). 
Investigational Sites: 
Up to thirty-five (35) sites will be utilized for this study throughout the 
United States (U.S.), Europe, and Australia/New Zealand. 
Study Population: 
Subjects will be males or non-pregnant females, at least 18 years of age, 
with symptomatic iliofemoral venous outflow obstruction and an 
expected lifespan sufficient to allow for completion of all study 
procedures.  
 
 
Eligibility Criteria: 
Inclusion Criteria 
1. The subject provides written informed consent using an Informed 
Consent Form (ICF) that is reviewed and approved by the Ethics 
Committee (EC) / Institutional Review Board (IRB) for the site. 
2. Subject agrees to comply with the protocol-mandated follow-up 
procedures and visits. 
3. The subject is a male or non-pregnant female ≥ 18 years old with an 
expected lifespan sufficient to allow for completion of all study 
procedures. Female subjects of childbearing potential must have a 
negative pregnancy test (urine or blood) within 14 days prior to the 
index procedure. 
4. The subject has symptomatic (non-malignant) venous outflow 
obstruction in iliofemoral “venous segments” (unilateral obstruction of 
the common femoral vein, external iliac vein, common iliac vein, or any 
combination thereof) of ≥ 50% as determined by catheter contrast 
venography.   
5.  The subject has symptomatic venous outflow obstruction (non-
malignant) in iliofemoral venous segments with a Clinical-Etiology-
Anatomic-Pathophysiologic Score CEAP “C” ≥ 3 or a Venous Clinical 
Severity Score VCSS pain score of ≥ 2.  
6. The subject is able and willing to comply with any required medication 
regimen. 
7. The reference vessel diameter(s) (RVD) is (are) between 7mm and 
19mm as determined by the Investigator’s visual estimate.  
Exclusion Criteria 
1. The subject is unable or unwilling to provide written informed consent, 
or is unable or unwilling to conform to the study protocol follow-up 
procedures and visits. 
2. The subject is or plans to become pregnant during the study. 
3. The subject has contralateral disease of the common femoral vein,  
    external iliac vein, common iliac vein, or any combination thereof and 
    does not meet the venous outflow obstruction requirement as  
    determined by the treating Investigator or the target vessel has a  
    malignant obstruction. 
4. The subject is asymptomatic, has a CEAP “C” <3, or a VCSS pain 
     score of <2. 
5. The subject has a venous obstruction that extends into the inferior vena 
     cava (IVC) or below the level of the lesser trochanter. 
6. The subject has a known uncorrectable bleeding diathesis or active  
     coagulopathy. 

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7. The subject has a known allergy or sensitivity to Nickel or Titanium or 
     has intolerance to antiplatelet, anticoagulant or thrombolytic  
     medications required per the protocol 
8. The subject has a known allergy or sensitivity to contrast media, which 
     cannot be adequately pre-medicated. 
9.  The subject has any planned surgical interventions (other than pre- 
     stenting procedures of thrombolysis, thrombectomy, and/or vena cava 
     filter placement in patients at high risk for pulmonary embolism)  
     within 30 days prior to, or within 30 days after the planned study   
     procedure.  
10.The subject has a lesion(s) or occlusion(s) which cannot be traversed 
       with a guidewire.     
11.The subject has had prior stenting in the target vessel. 
12.The subject has iliofemoral venous segments unsuitable for treatment 
     with available sizes of study devices. 
13.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.   
14.The subject is currently participating in an investigational drug, 
     biologic, or another device study for which the investigational  
     treatment has not ended.  Studies requiring extended follow-up for 
     products that are now commercially available are not considered 
     investigational studies. 
15.The subject is currently on dialysis or has a serum creatinine ≥ 2.5  
      mg/dl.      
 
Procedures: 
All subjects will undergo a clinical evaluation at baseline/screening (prior 
to index procedure); treated subjects will undergo additional clinical 
evaluations prior to hospital discharge, at 30-days and 6-, 12-, 24- and 36-
months post-index procedure.   
Primary Endpoint: 
Safety: 
Freedom from Major Adverse Events (MAEs) through 30 days  
Defined as the following: 
• 
Device and/or procedure related death 
• 
Major amputation of target limb 
• 
Pulmonary Embolism which is clinically important (symptomatic 
with chest pain, hemoptysis, dyspnea, hypoxia, etc.) 
• 
Target Vessel Revascularization (TVR) 
• 
Vascular injury requiring surgical/endovascular intervention 
• 
Embolization/migration of stent 
• 
Device or procedure related acute DVT involving the treated limb 
Efficacy:  
Primary Patency rate at 12 months defined as  
Freedom from TVR; freedom from thrombus occlusion and stenosis > 50% 
as measured by DUS.  Note:  Venography will be used only if investigator 
cannot successfully measure endpoint by DUS or if the investigator deems 
there is clinical need to perform invasive venography. 

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Secondary Endpoints: 
− 
Evaluation of VCSS Scores at 30 days, 6, 12, 24, and 36 months 
Quality of Life Questionnaire (QOL) at 30 days, 6, 12, 24, and 36 
months  
− 
Evaluation of CEAP Scores at 30 days, 6, 12, 24, and 36 months 
− 
Acute Procedure Success  
− 
Lesion Success 
− 
Acute Technical Success  
− 
Freedom From Target Lesion Revascularization (TLR) at 30 days 
6, 24, 36 months 
− 
Freedom From Target Vessel Revascularization (TVR) at 30 days, 
6, 24, 36 months 
− 
Primary Patency at 24, 36 months 
− 
X-ray analysis for stent fracture at 12, 24, and 36 months 
 
Lead Principal 
Investigator: 
Michael Dake, MD 
Thelma and Henry Doelger Professor (III) 
Department of Cardiothoracic Surgery 
Stanford University School of Medicine 
Falk Cardiovascular Research Center 
300 Pasteur Drive 
Stanford, CA 94305-5407 
Telephone: 650.725.6407 
Fax: 650.725.3846 
Email: mddake@stanford.edu 
 
European Co-Principal 
Investigator 
Gerard O’Sullivan, MD 
University Hospital Galway 
Newcastle Road 
Galway, Ireland 
H91 YR71 
Telephone: +353(91)542356 
Email: Gerard.osullivan2@hse.ie 
Venographic Core 
Lab: 
Alexandra J. Lansky, MD 
Yale Cardiovascular Research Group 
1 Church Street, Suite 330 
New Haven, CT 06510 
Telephone: (203) 737-2142  
Duplex Ultrasound 
Core Lab: 
Ido Weinburg, MD, MSc, MHA,FSVM, RPVI 
Vascular Ultrasound Core Lab 
Massachusetts General Hospital 
One Bowdoin Square 
Boston, MA 02114  
Telephone: (617) 726-5552  
 
Please refer to Site Contacts List for all Sponsor, Investigator, and Vendor contact information. 

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1 
STATISTICAL ANALYSIS PLAN 
 
1.1. 
Analysis Populations 
Several populations of patients enrolled into the trial need to be defined. 
 
The intent-to-treat (ITT) population consists of those subjects who have signed the Informed Consent 
Form and had the VENOVO™ Venous Stent catheter introduced (i.e., delivery system enters the 
subject’s body). 
 
Subjects who do not receive the study implant (section 5.2.2), but in whom the VENOVO™ Venous 
Stent catheter was introduced will be included in the ITT population.  Subjects who need more than 
two (2) VENOVO™ Venous Stents (section 5.2.3) or undergo other treatment modalities (section 5.2.4) 
will be included in the ITT population.   
A per-protocol (PP) population may be created if there are subjects who have any major protocol 
deviations. Major Protocol Deviations are defined as those that occur to protect the life or physical 
well-being of a subject in an emergency, or those that may affect the scientific soundness of the study, 
or the rights, safety or welfare of human subjects.  The PP population will consist of any subjects in the 
ITT population who receive at least one stent and do not have any major protocol deviations, including 
deviations of study eligibility criteria.    Subjects who need more than two (2) VENOVO™ Venous 
Stents, require placement of a commercially-available stent (section 5.2.3), or undergo other treatment 
modalities (section 5.2.4) will be excluded from the PP population.   
All effectiveness and safety analyses including the primary analysis will be primarily based on the 
ITT population. A PP analysis may also be performed for the primary endpoint. It will only serve as a 
sensitivity analysis for the primary analysis which is based on the ITT population. 
 
1.2.     Primary Endpoints: Primary Study Hypotheses  
For this study, the primary efficacy and primary safety endpoint will be considered as co-primary 
endpoints. That is, both primary efficacy and safety endpoint need to be significant to claim the study 
as successful. 
 
1.2.1.   Primary Efficacy Endpoint 
The Primary Efficacy endpoint is  the primary patency of the VENOVO™ Venous Stent (BVS) at 12 
months post index procedure, which need to be better than the Performance Goal (PG) (74%) developed 
from the patency of other marketed stents at 12 months (see section 6.4 sample size consideration for 
the derivation of the PG).  
The primary efficacy endpoint will be evaluated by the following hypothesis: 
H0:  
The primary patency rate at 12 months post index procedure from the overall  VENOVO™ 
Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG; 
Ha:  
The primary patency rate at 12 months post index procedure from the overall  VENOVO™ 
Venous Stent (BVS) patients (PTS and NIVL combined)is better than that of the PG; 
 
H0: 0.45 × 𝜋𝑁𝐼𝑉𝐿+ 0.55 × 𝜋𝑃𝑇𝑆≤𝑃𝑃𝑃𝐺 v.s Ha: 0.45 × 𝜋𝑁𝐼𝑉𝐿+ 0.55 × 𝜋𝑃𝑇𝑆> 𝑃𝑃𝑃𝐺 

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Where 𝜋𝑃𝑇𝑆is the true primary patency rate at 12-month post index procedure for PTS patients, 𝜋𝑁𝐼𝑉𝐿 
is the true primary patency rate at 12-month post index procedure for NIVL patients, and 
PPPG=74%.The test statistics can be formulated as: 
 
𝑍=
0.45 × 𝑝𝑁𝐼𝑉𝐿+ 0.55 × 𝑝𝑃𝑇𝑆−0.74
√(0.45)2 × 𝑃𝐺𝑁𝐼𝑉𝐿(1 −𝑃𝐺𝑁𝐼𝑉𝐿)
𝑛𝑁𝐼𝑉𝐿
+ (0.55)2 × 𝑃𝐺𝑃𝑇𝑆(1 −𝑃𝐺𝑃𝑇𝑆)
𝑛𝑃𝑇𝑆
 
 
Where 𝑝𝑃𝑇𝑆 and 𝑝𝑁𝐼𝑉𝐿 are observed primary patency rate at 12-month post-index procedure for PTS 
and NIVL patients, respectively. 𝑃𝐺𝑃𝑇𝑆 (=77%-10%=67%) and 𝑃𝐺𝑁𝐼𝑉𝐿 (=93%-10%=83%) are 
expected value for PTS and NIVL patients under the null; 𝑛𝑃𝑇𝑆 and 𝑛𝑁𝐼𝑉𝐿 are the number of PTS and 
NIVL patients in the analysis. A one-sided p-value will be calculated using a normal distribution. The 
study device will be considered to have achieved the primary efficacy objective if the one-sided p-
value is less than 0.05.   
 
1.2.2.    Primary Safety Objective 
The primary safety endpoint of the study is freedom from major adverse events (MAEs) and freedom 
from TVR through 30 days post-index procedure, as adjudicated by a Clinical Events Committee 
(CEC). The performance goal of free from primary safety event is 89%.   
The primary safety endpoint will be evaluated by the following hypothesis: H0:  
The primary safety 
endpoint absence from event rate in the VENOVO™ Venous Stent (BVS) through 30 day at 
most as large as that of the PG; 
Ha:  
The primary safety endpoint absence from event rate in the VENOVO™ Venous Stent (BVS) 
through 30 day is better than that of the PG; 
 
Ho:  MBVS < MPG 
Ha:  MBVS > MPG 
 
Where MPG=89% 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.   
 
 
1.2.3. Handling of Missing Data 
Study endpoints may be missing due to withdrawal of consent, investigator’s decision to terminate, lost 
to follow-up and death. As long as the missing data is unrelated to the study intervention and the 
observed and unobserved data, limiting the analysis to those subjects who contribute endpoints 
produces unbiased estimates of the event rates. 
 
 
The reason for missing data in any subject will be reported.  If there is any indication that missing data 
is related to the study intervention, a worst-case analysis may be performed in addition to the standard 
analysis.  In a worst-case analysis, a failure of effectiveness or safety will be assumed to have occurred 
at the time the subject was censored. 
 

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In addition, regardless of whether missing data are related to the study intervention, a tipping-point 
analysis will 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. 
 
Multiple imputation will also be explored as another method to handle missing data. 
 
1.2.4. Assessment of Poolability of Sites 
The sites will be tested for potential differences in the primary endpoint.  Sites with fewer than 10 
treated subjects will be combined for this purpose. The pooling will be restricted within country.  The 
sites with less than 10 treated subjects will be sorted by site number within each country 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 sites effect is 
< 0.15, it will be considered as evidence of statistical significance. 
 
If there are any site effects, the sites that have similar and dissimilar results will be grouped and 
exploratory analyses will be performed to investigate the potential reason for the differences among 
sites. 
 
An analysis will be performed to examine the potential difference in the primary endpoint between the 
two geographic regions (US vs. OUS).  A logistic regression model will be fit that includes fixed effect 
for geography.  If the p-value of the geography effect is <0.15, it will be considered evidence of a 
statistically significant difference between the geographic regions, 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. 
 
 
1.3.     Evaluation of Secondary Endpoints (with and without hypotheses) 
 
1.3.1. Control of Study-wise Type I Error 
The Secondary Endpoints will be evaluated and tested only if the Primary Safety and Effectiveness 
hypotheses pass (i.e., both Primary non-inferiority tests reject the null hypothesis).  Two of the 4 
secondary endpoints will include a hypothesis test. They will be tested along with the inequality test of 
the Primary Efficacy Objective. The method of adjusting the α-level of the tests described below will 
be used to ensure that the study-wide error rate does not exceed 0.05. 
 
The Hochberg method for controlling multiple comparison will be used. Two p-values will be obtained 
for the two Secondary Endpoints with hypothesis tests. If the larger p-value is less than 0.05, then both 
endpoints are considered statistical significant; otherwise, if the larger p-value is greater than 0.05, the 
smaller p-value need to be less than 0.025 to claim statistical significance for that endpoint with smaller 
p-value.  
 
1.3.2. Analysis of the VCSS Pain Assessment 
The first Secondary Objective is to evaluate whether the VCSS Pain Assessment of the BVS improves 
between the baseline classification and the follow-up classifications at 6, 12, 24, and 36 months.  The 

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emphasis will be on the change between baseline and 12 months, since that is the time of the endpoint 
for the Primary Efficacy Objective.  The four classes of VCSS for pain have been discussed previously 
in this Investigational Plan. (The VCSS includes clinical signs and symptoms other than pain, but this 
objective focuses only on pain.) 
 
The objective is to demonstrate that the distribution of classifications improves from baseline to each 
follow-up time, especially at 12 months.  This requires testing the null hypothesis (Ho) that the 
distribution at the 12-month follow-up (DBVS@12M) remains unchanged compared to baseline (DBVS@BL) 
against the alternative hypothesis (Ha) that the distribution shifts toward lower (less pain) classes: 
Ho:  DBVS@12M > DBVS@BL 
vs 
Ha:  DBVS@12M < DBVS@BL 
 
The endpoint for each study subject is the VCSS pain class at baseline and at each follow-up time (6, 
12, 24, and 36 months). 
 
 
Paired mean difference of the 12-month follow-up and baseline pain score and 95% CI will be 
presented. If the mean difference < 0 and the two-sided p-value from the paired t-test is deemed 
significant based on the appropriate α-level as described above, this will indicate success for this 
endpoint. 
 
In addition, the VCSS pain class at each time point will be summarized descriptively.. 
 
1.3.3. Analysis of the Quality of Life (CIVIQ-20 Assessment) 
The second Secondary Objective is to evaluate whether the QoL Assessment of the BVS improves 
between the baseline classification and the follow-up classifications at 6, 12, 24, and 36 months.  The 
emphasis will be on the change between baseline and 12 months, since that is the time of the endpoint 
for the Primary Efficacy Objective.  The QoL instrument will be the CIVIQ-20 and its use in the trial 
has been discussed previously in this Investigational Plan. 
 
The objective is to demonstrate that the mean improves from baseline to each follow-up time, especially 
at 12 months.  This requires testing the null hypothesis (Ho) that the mean score at the 12-month follow-
up (QoLBVS@12M) remains unchanged compared to baseline (QoLBVS@BL) against the alternative 
hypothesis (Ha) that the mean is lower (better): 
 
Ho:  QoLBVS@12M > QoLBVS@BL 
vs 
Ha:  QoLBVS@12M < QoLBVS@BL 
 
The endpoint for each study subject is the CIVIQ-20 score at baseline and at each follow-up time (6, 
12, 24, and 36 months). 
 
The QoL hypothesis test: 
 
Ho:  QoLBVS@12M > DBVS@BL vs 
Ha:  QoLBVS@12M < DBVS@BL 
 
will be tested using a paired t-test with the appropriate α-level as described above.   
 

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In addition, descriptive statistics of total CIVIQ-20 score as well as score of each dimension at each 
time point will be presented by visit. 
1.3.4. Analysis of the CEAP Scores 
The third Secondary Objective is to assess the CEAP scores at baseline, 6, 12, 24, and 36 months. Each 
classification factors at each time points will be summarized descriptively. No hypotheses will be 
tested. 
 
1.3.5. Analysis of other Secondary Objective 
The following secondary endpoints are intended to be reported in the device’s labeling and will be 
summarized using descriptive statistics (sample size of reported values, means or proportions, standard 
deviations, and 95% confidence intervals). The details of the definition of the secondary endpoints are 
described in Section 3.2. 
 
− Acute Procedure Success  
− Lesion Success 
− Acute Technical Success  
− Target Lesion Revascularization (TLR) 
− Target Vessel Revascularization (TVR) 
− Patency at 24 and 36 months  
− X-ray analysis for fracture at 12, 24, and 36 months  
 
1.4. 
Sample Size Consideration 
Primary Efficacy Endpoints: 
 
Table 6.3-1 shows the possible combinations of proportions of patients that could be enrolled in the 
study along with the weighted mean primary patency (PP) and the sample size required for 85% power 
against the PG (PPPG). 
 
Bard has chosen the sample size for the trial required for 85% power when the proportion of NIVL 
patients with endpoints is 20% and the proportion of PTS patients is 80%.  This is the company’s best 
guess for the actual enrollment. The estimate from the literature of the PP is 80% (used as the alternative 
proportion in the sample size estimate) and the PPPG is 70% (used as the null proportion). The sample 
size is 138 patients.  (This row is highlighted in yellow in Table 1.3-1.).  With 45:55 split of the sample 
size, the PPPG becomes 74%. As indicated in Table 6.3-1, the sample size required for 85% power will 
be between 121 and 125, which is less than planned sample size 138. In other words, with the same 
sample size as planned, >85% power can be achieved. 
  
 
All sample size estimates in Table 1.3-1 were made with PASS 12 (Hintze, J. (2013). PASS 12. NCSS, 
LLC. Kaysville, Utah, USA. www.ncss.com ) using the Fisher’s Exact Binomial test for one proportion. 
 
Note that the sample size of 138 patients is the number of evaluable patients.  Up to 170 patients may 
be enrolled, depending on the losses-to-follow-up, deaths, and study withdrawals. Bard further 
estimates that approximately 50% of consented subjects will not meet the eligibility criteria (i.e., will 

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be Screen Failures), and therefore will not be enrolled in the study.  The estimated consented population 
will therefore be 340 (170/.5 = 340).  
 
 
Table 1.3 -1. Estimates of the Sample Size Based on the Proportions of NIVL and PTS Subjects 
in the Clinical Trial 
 
NIVL % 
PTS % 
Weighted 
Mean PP 
α 
Performance 
Goal (PPPG) 
Sample Size 
of BVS for 
85% Power 
5% 
95% 
77.9% 
5% 
68% 
146 
10% 
90% 
78.7% 
5% 
69% 
140 
20% 
80% 
80.4% 
5% 
70% 
138 
30% 
70% 
82.0% 
5% 
72% 
132 
40% 
60% 
83.6% 
5% 
74% 
125 
50% 
50% 
85.2% 
5% 
75% 
121 
60% 
40% 
86.9% 
5% 
77% 
112 
 
 
Primary Safety Endpoint: 
 
The freedom-from-MAE rate estimated from the literature was 99%, which was used as the alternative 
proportion.  The null proportion was the MPG of 89%. With 42 BVS subjects, the study will have 85% 
power to detect a difference, and with 138 BVS subjects, the study power will be over 99%. 
 
Overall study power: with taking into consideration of both co-primary efficacy and safety endpoints, 
with 138 BVS subjects, the overall study power is at least 85%*99%=84%.