CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
Phase: NA
Conditions: Superficial Femoral Artery Stenosis
Sponsor: C. R. Bard

 
 
  
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
 
Title:                            
CONTINuous Infra-Inguinal Stenting Using the Bard 
LifeStent® VascUlar Stent SysteMs (“CONTINUUM”) 
 
Protocol Number:    
BPV-08-001 
 
Study Type: 
 
Post-Approval Study 
 
Date:  
 
 
April 16, 2014 
 
Version: 
 
 
Version 6.0 
 
Study Device: 
Bard® LifeStent® Vascular Stent System and LifeStent® XL 
Vascular Stent System  
 
Sponsor: 
  
 
Bard Peripheral Vascular, Inc. (“Bard”) 
 
  
 
A division of C. R. Bard, Inc. 
 
  
 
1625 West 3rd Street  
 
  
 
Tempe, Arizona 85281 
 
Sponsor Contacts: 
 
Talar Saber 
Associate Project Manager, Clinical Affairs 
Telephone: (480) 379-2839 
Fax: (480) 449-2542  
E-mail: talar.saber@crbard.com  
 
 
Medical Monitor (MM):      Bill Altonaga, M.D. 
 
1905 Bayhill Drive 
 
Melbourne, FL  32940 
 
E-mail: bill.altonaga@crbard.com  
 
NCT Number: 00908947 (NCT Number added post-approval per CT.gov requirement)  
 
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of Bard Peripheral Vascular, Inc. or its affiliates.  Neither this document nor the information herein may be reproduced, used, or 
disclosed to or for the benefit of any third party without the prior consent of Bard Peripheral Vascular, Inc.   
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CONTINUUM PROTOCOL SUMMARY 
 
Title:  
CONTINUUM 
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® 
VascUlar Stent SysteMs  
Objectives: 
The objective of this study is to collect post-market confirmatory 
evidence of the safety and effectiveness of the Bard® LifeStent® 
Vascular Stent System, the LifeStent® XL Vascular Stent System, 
and the LifeStent® SOLO™ system (together the “LifeStent® Vascular 
Stent System”). 
Design: 
This study is a prospective, multi-center, single-arm, non-randomized 
study enrolling subjects with lifestyle-limiting claudication or 
ischemic rest pain attributable to lesion(s) (stenosed, occluded, 
restenosed, or re-occluded) in the infra-inguinal segment (superficial 
femoral artery (SFA) and/or proximal popliteal artery) that are 
amenable to treatment by percutaneous transluminal angioplasty 
(PTA) and stenting.  Investigators should select an appropriately 
sized device(s) to treat subjects with target lesion(s) up to 240 mm.   
 
Clinical follow-up for all subjects will be performed at hospital 
discharge, 30-days and 12-, 24-, and 36-months post-procedure. 
Sponsor: 
Bard Peripheral Vascular, Inc. (“Bard”) 
1625 West 3rd Street 
Tempe, Arizona 85281 USA 
Devices: 
Bard® LifeStent® Vascular Stent Systems: 
 
Stent Diameters:        
         6.0 and 7.0 mm 
 
Stent Lengths:   LifeStent® 
         20, 30, 40, 60 and 80 mm 
                           LifeStent® XL             100, 120, 150 and 170 mm 
 
 
   LifeStent® SOLO™    20, 30, 40, 60, 80, 100, 120, 
150, 170, and 200 mm 
 
Enrollment: 
A minimum of two-hundred thirty-four (234) subjects in a non-
randomized fashion. 
 
At least 64 subjects with target lesion lengths < 160 mm and at least 
64 subjects with target lesion lengths > 160 mm and ≤ 240 mm will 
be enrolled.  In addition to the original 170 subjects required, at least 
64 additional subjects treated with the 200 mm LifeStent® will be 
enrolled.  
 

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Investigational Sites: 
Up to thirty-five (35) investigational sites (“sites”) will be utilized for 
this study.  
Procedures: 
Subjects will undergo a clinical evaluation at baseline/screening 
(prior to index procedure), prior to hospital discharge, 30-days and 
12-, 24- and 36-months post-procedure.  
Medications: 
Pre-Procedure: 
Subjects are to receive a minimum of 81 mg of aspirin (ASA) orally 
per day and a minimum of 75 mg of Clopidogrel orally per day, 
beginning the day of the index procedure, and no later than 2 hours 
following the index procedure.   
 
Post-Procedure: 
Subjects are to continue to receive a minimum of 81 mg of ASA 
orally per day for a recommended minimum of 6 months, and a 
minimum of 75 mg of Clopidogrel orally per day for a minimum of 
12 weeks. 
Study Population: 
The study population will be comprised of subjects who present with 
lifestyle-limiting claudication or ischemic rest pain and are 
candidates for PTA and stenting. 
 
Prior to enrollment, each subject will have a diagnostic assessment 
that enables qualification of the target lesion(s).  Subjects with 
lesion(s) in the infra-inguinal segment (SFA and/or proximal 
popliteal arteries) will be considered for enrollment.  The reference 
vessel diameter must be > 4.0 mm and < 6.5 mm. 
Primary Endpoints: 
 
Safety (Death):  
− Freedom from occurrence of death at 30-days and 12-months 
post-index procedure. 
 
Effectiveness (Device Success): 
− Freedom from acute delivery failure; and, 
− Primary Target Lesion Patency (TLP) at 12-months post-index 
procedure. 

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Secondary Endpoints 
 
 
− Freedom from Target Lesion Revascularization (TLR) and/or Target 
Vessel Revascularization (TVR) at 12-months post-index procedure. 
− Secondary Device Success (compared to RESILIENT LifeStent®). 
− Primary Safety of the Target Lesion Lengths > 160 mm subgroup 
compared to the Target Lesions treated with the 200 mm LifeStent® 
subgroup. 
− Primary Safety of the following subgroups: 1) Target Lesion 
Lengths ≤ 160 mm, 2) Target Lesion Lengths > 160 mm and ≤ 240 
mm, and 3) Target Lesions treated with the 200 mm LifeStent®. 
− Primary Effectiveness of the Target Lesion Lengths > 160 mm 
subgroup compared to the Target Lesions treated with the 200 mm 
LifeStent® subgroup. 
− Primary Effectiveness of the following subgroups: 1) Target Lesion 
Lengths ≤ 160 mm, 2) Target Lesion Lengths > 160 mm and ≤ 240 
mm, and 3) Target Lesions treated with the 200 mm LifeStent®. 
− Freedom from Fracture (FFF) at 12- and 24-months post-index 
procedure. 
− Primary TLP (Sustained and Expanded) for Target Lesion Lengths > 
160 mm at 12-, 24- and 36-months post-index procedure. 
− Freedom from TLR and/or TVR for Target Lesion Lengths > 160 
mm at 12-, 24-, and 36-months post-index procedure.   
− Secondary Safety defined as freedom from death (excluding 30-days 
and 12-months post-index procedure), stroke, myocardial infarction 
(MI), emergent surgical revascularization, significant distal 
embolization in target limb, target limb major amputation, and 
thrombosis of target vessel at 30-days and 12-, 24-, and 36-months 
post-index procedure. 
− Acute Technical Success defined as successful deployment of the 
stent to the intended location. 
− Acute Lesion Success defined as attainment of ≤ 30% residual 
stenosis of the target lesion using any percutaneous method and/or 
non-investigational device (i.e., post-dilatation).   
− Acute Procedure Success defined as lesion success and no peri-
procedural complications (death, stroke, MI, emergent surgical 
revascularization, significant distal embolization in target limb, and 
thrombosis of target vessel). 
− Sustained Freedom from TLR and/or TVR at 24- and 36-months 
post-index procedure 
− Sustained Hemodynamic Success defined as sustained improvement 
of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-
days and 12-, 24-, and 36-months post-index procedure without the 
need for repeated TLR in surviving subjects. 
− Sustained Clinical Success defined as sustained cumulative 
improvement from baseline value of ≥ 1 category according to 
Rutherford et al11 at 30-days and 12-, 24-, and 36-months post-index 
procedure without the need for repeated TLR in surviving subjects. 

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− Sustained TLP at 24- and 36-months post-index procedure 
corresponding to PSR < 2.5. 
− Expanded TLP at 12-, 24- and 36-months post-index procedure 
corresponding to PSR < 3.0. 
− Cumulative (primary-assisted and secondary) TLP at 12-, 24-, and 
36-months post-index procedure corresponding to PSR < 2.5, and 
PSR < 3.0. 
− Quality of Life as assessed by Walking Impairment Questionnaire 
(WIQ) at baseline, 30-days and 12-, 24- and 36-months post-index 
procedure. 
Principal 
Investigators: 
Mark D. Mewissen, MD 
Aurora St. Luke’s Medical Center 
2900 West Oklahoma Avenue 
Milwaukee, WI 53215 
 
Jeffrey P. Carpenter, MD 
The Cooper Health System 
1 Cooper Plaza 
Camden, NJ 08103 
Clinical Affairs: 
Talar Saber 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, Arizona 85281  USA 
Contract Research 
Organization/Data 
Coordinator Center 
 
Amy L. Stroud 
Project Manager 
Novella Clinical, Inc. 
4309 Emperor Boulevard, Suite 400 
Durham, NC  27703 
Telephone: (919) 972-2442 
Fax: (919) 484-7727 
Email: astroud@novellaclinical.com  
Angiographic/X-Ray 
Core Lab: 
Phillippe Genereux, MD 
Cardiovascular Research Foundation 
111 East 59th St, 12th Floor  
New York, NY 10022 
Telephone:  (646) 434-4571 
Duplex Ultrasound 
Core Lab: 
Michael R. Jaff, DO, FACP, FACC 
VasCore 
62 Staniford Street 
Boston, MA  02114 
Telephone: (617) 726-5552 
  

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Statistical Analysis Plan 
1. Study Endpoints 
Primary and two secondary effectiveness endpoints (i.e., freedom from TLR/TVR through 12-
months post-index procedure, and secondary device success) will be compared to the RESILIENT 
trial results (historical control). 
A. Primary Safety Endpoint 
The primary safety endpoint of the study is defined as: Freedom from occurrence of death at 30-
days and 12-months post-index procedure.   
B. Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the study, device success, will collectively measure both 
acute and chronic effectiveness.  
Acute effectiveness is defined as: Successful delivery of the stent to the intended site with the post-
deployment stent length being within 10% of the pre-deployment stent length.  
Chronic effectiveness is defined as: Primary Target Lesion Patency (TLP) at 12-months post-
index procedure, as measured by DUS. TLP is defined as the interval following the index 
procedure until a DUS assessment indicates that the target lesion(s) is no longer patent; that is, 
the treated segment has a peak systolic velocity ratio (PSR) ≥ 2.5. PSR is determined by 
comparing velocities within the treated segment to the proximal normal arterial segment. In this 
study, a > 50% stenosis is defined as a PSR of ≥ 2.5.  
C. Secondary Endpoints 
1. Freedom from TLR and/or TVR through 12-months post-index procedure. TLR is defined 
as the interval following the index procedure until the first revascularization procedure (e.g. 
PTA, cryoplasty, etc.) of the target lesion. TVR is defined as the interval following the index 
procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) 
in the target vessel.   
 
2. Secondary Device Success (compared to RESILIENT LifeStent®).  
 
3. Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index 
procedure) of the Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions 
treated with the 200 mm LifeStent® subgroup.  
 
4. Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index 
procedure) of the following subgroups: 1) Target Lesion Lengths ≤ 160 mm, 2) Target Lesion 
Lengths > 160 mm and ≤ 240 mm, and 3) Target Lesions treated with the 200 mm LifeStent®.  
 
5. Primary Effectiveness (Device Success) of Target Lesion Lengths > 160 mm subgroup 
compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.  

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6. Primary Effectiveness (Device Success) of the following subgroups: 1) Target Lesion 
Lengths ≤ 160 mm, 2) Target Lesion Lengths > 160 mm and ≤ 240 mm, and 3) Target 
Lesions treated with the 200 mm LifeStent®.  
 
7. Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.  
 
8. Primary TLP (Sustained and Expanded) for Target Lesion Lengths > 160 mm at 12, 24- 
and 36-months post-index procedure corresponding to PSR values of < 2.0, <2.5, and < 3.0.  
 
9. Freedom from TLR and/or TVR for Target Lesion Lengths > 160 mm at 12-, 24-, and 
36-months post-index procedure.  
 
10. Secondary Safety defined as freedom from death (excluding 30-days and 12-months post-
index procedure), stroke, MI, emergent surgical revascularization, significant distal 
embolization in target limb, target limb major amputation, and thrombosis of target vessel at 
30-days and 12-, 24-, and 36-months post-index procedure. 
 
11. Acute Technical Success defined as successful deployment of the stent to the intended 
location.  
 
12. Acute Lesion Success defined as attainment of ≤ 30% residual stenosis of the target lesion 
using any percutaneous method and/or non-investigational device (i.e., post-dilatation).   
 
13. Acute Procedure Success defined as lesion success and no peri-procedural complications 
(death, stroke, MI, emergent surgical revascularization, significant distal embolization in 
target limb, and thrombosis of target vessel). 
 
14. Sustained Freedom from TLR and/or TVR at 24- and 36-months post-index procedure.  
 
15. Sustained Hemodynamic Success defined as sustained improvement of Ankle-Brachial 
Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index 
procedure without the need for repeated TLR in surviving subjects.  
 
16. Sustained Clinical Success defined as sustained cumulative improvement from baseline 
value of ≥ 1 category according to Rutherford et al.1 at 30-days and 12-, 24-, and 36-months 
post-index procedure without the need for repeated TLR in surviving subjects.  
 
17. Sustained TLP at 24- and 36-months post-index procedure corresponding to PSR < 2.5.   
 
18. Expanded TLP at 12-, 24- and 36-months post-index procedure corresponding to PSR < 3.0.  
 
19. Cumulative (primary-assisted and secondary) TLP at 12-, 24-, and 36-months post-index 
procedure corresponding to PSR < 2.5 and PSR < 3.0. 
 
20. Quality of Life as assessed by Walking Impairment Questionnaire (WIQ) at baseline, 30-
days and 12-, 24- and 36-months post-index procedure.  

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2. Study Design 
A. Overview 
This study is a prospective, multi-center, single-arm, non-randomized study enrolling subjects with 
lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, 
restenosed, or re-occluded) in the infra-inguinal segment (superficial femoral artery (SFA) and/or 
proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty 
(PTA) and stenting. Investigators should select an appropriately sized device(s) to treat subjects with 
target lesion(s) up to 240 mm. Clinical follow-up for all subjects will be performed at hospital 
discharge, 30-days and 12-, 24-, and 36-months post-procedure.  
 
B. Study Population 
The study population will consist of subjects with lifestyle-limiting claudication or ischemic rest 
pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal 
segment (SFA) and/or proximal popliteal artery) that are amenable to treatment by PTA and 
stenting.  The reference vessel diameter must be ≥ 4.0 mm and ≤ 6.5 mm. 
A minimum of 234 subjects will be enrolled at up to 25 sites throughout the United States.    
C. Sample Size Determination 
The protocol includes sample size considerations for the primary safety endpoint, the primary 
effectiveness endpoint and two secondary effectiveness endpoints (freedom from TLR/TVR 
through 12-months post-index procedure, and secondary device success).  The secondary 
effectiveness (device success) endpoint required the largest sample size based on the following 
considerations: 
Objective: To demonstrate that device success (combined acute and chronic 
effectiveness) in the CONTINUUM LifeStent® group is not inferior to the observed device 
success of the RESILIENT12 LifeStent® group at 12-months post-index procedure.  
H0: The device success rate at 12-months post-index procedure with CONTINUUM 
LifeStent® (PCONTINUUM) is inferior to the device success rate with RESILIENT12 
LifeStent® (PRESILIENT).  
H1: The device success rate at 12-months post-index procedure with CONTINUUM 
LifeStent® (PCONTINUUM) is not inferior to the device success rate with RESILIENT12 
LifeStent® (PRESILIENT).  
H0: PCONTINUUM < PRESILIENT – δ vs. H1: PCONTINUUM > PRESILIENT – δ 
The sample size estimate assumes the following:  

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1. The acute effectiveness failure rate was approximately 10% and the TLP failure rate was 18% 
in the RESILIENT LifeStent® group. Thus, the success rate at 12-months post-index procedure 
was 72%.  
2. The acute effectiveness failure rate in the CONTINUUM LifeStent® group is expected to be 
1%. The TLP failure rate in the CONTINUUM LifeStent® group is expected to be equal to the 
RESILIENT LifeStent® group when the rates are adjusted for disease severity using the Cox’s 
regression covariates (Rutherford Category, target lesion(s) lengths, total treated segment length 
and perhaps age, gender, etc.). Thus, the success rate at 12-months post-index procedure is 
expected to be 81%.  
3. The number of subjects in the RESILIENT LifeStent® group was 134, and 112 subjects were 
evaluable for TLP at 12-months post-index procedure.  
4. A Cox’s time-to-event (survival) analysis with regression covariates will be used to estimate 
the survival proportions and their standard errors.  
5. The Type 1 error, α = 0.05 (one-sided because the hypothesis is non-inferiority).  
6. The Type 2 error, β ≤ 0.20 (Power = 1 - β = 80%).  
7. Non-inferiority margin, δ = 7.5%.  
8. The censoring rate through 12-months post-index procedure will be 15%.  
According to PASS 2008 (using the Cox’s survival analysis module), the sample size required 
for 80% power is 252 subjects with just over 50% in one of the groups. The RESILIENT 
LifeStent® group has 112, so implanting 140 (56%) or more CONTINUUM LifeStent® subjects 
will provide at least 80% power. When this is inflated to accommodate 15% censoring through 
12-months post-index procedure, the CONTINUUM sample size is 165 subjects.  This sample 
size estimate demonstrates that secondary effectiveness (device success) is the sample-size driver for 
this study.  
However, a minimum of 170 subjects are required to be enrolled as originally agreed upon and 
referenced in the FDA Post-Market Approval (PMA) Approval Order of the Bard® LifeStent® 
Vascular Stent (P070014). The secondary endpoint, “Device Success” demonstrated that 165 subjects 
are necessary to power this endpoint, including adjusting for censoring; this is very close to the 170 
subjects initially stipulated by FDA. In addition to this requirement, at least 64 additional subjects 
treated with the 200 mm LifeStent® will be enrolled (including adjustment for censoring), which 
results in a minimum enrollment of 234 subjects in the study. 
D. Assessment Schedule 
Subjects will undergo a clinical evaluation at baseline/screening (prior to index procedure), prior 
to hospital discharge, 30-days, and 12-, 24-, and 36-months post-procedure. 

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Time and Events Schedule 
Observation 
Baseline/ 
Screening 
Intra- 
Procedure 
Hospital 
Discharge 
30 d 
(± 7d) 
12 mo 
(± 30d) 
24 & 36 mo 
(± 30d) 
Eligibility Criteria 
✓ 
✓ 
 
 
 
 
Informed Consent 
✓ 
 
 
 
 
 
Demographics 
✓ 
 
 
 
 
 
Medical History 
✓ 
 
 
 
 
 
BUN/Creatinine and CBC 
✓ 
 
 
 
 
 
Pregnancy test HCG 
✓1 
 
 
 
 
 
*Concomitant Medications 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
Comprehensive Physical Exam 
✓ 
 
✓ 
✓ 
✓ 
✓ 
Angiogram 
✓2 
✓3 
 
 
 
 
Resting ABI 
✓ 
 
✓ 
✓4 
✓ 
✓ 
Rutherford (Category & Grade) 
✓ 
 
 
✓ 
✓ 
✓ 
Adverse Event Assessment 
 
✓ 
✓ 
✓ 
✓ 
✓ 
X-Ray (AP & lateral) 
 
 
 
 
✓3 
✓3,5 
Color Flow Duplex Ultrasound 
 
 
 
✓6 
✓6 
✓6 
Quality of Life Questionnaire 
✓ 
 
 
✓ 
✓ 
✓ 
1Perform urine pregnancy test for women who are of childbearing potential < 7 days prior to enrollment.  
2Baseline angiogram may be performed, 30 days prior to study enrollment or day of study enrollment just prior to intervention  
3Send images to Angiographic/X-Ray Core Laboratory  
4Only required if subject’s symptoms/vascular function has worsened.  
5X-Ray Not Required at 36-Month Follow-Up.  
6Send images to Ultrasound Core Laboratory 
*Concomitant Medications; only record (anti-platelets, anti-coagulants, and direct thrombin inhibitors)