A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the Clinical Use of the Caterpillar™ Arterial Embolization Device for Arterial Embolization in the Peripheral Vasculature (MONARCH)
Phase: NA
Conditions: Embolization, Therapeutic
Sponsor: C. R. Bard

 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
 
CLINICAL STUDY PROTOCOL 
 
Title:   
A Prospective, Multi-Center, Single-Arm, Real World Study 
Assessing the Clinical Use of the Caterpillar™ Arterial 
Embolization Device for Arterial Embolization in the 
Peripheral Vasculature (MONARCH) 
 
Protocol Number:   
BPV-18-001 
 
Study Type:  
Post-Market 
 
Date:   
December 17th, 2020 
 
Version: 
2 
 
Study Device:  
Caterpillar™ Arterial Embolization Device 
 
Sponsor:  
Bard Peripheral Vascular, Inc. 
 
1625 West 3rd Street 
 
Tempe, AZ 85281, USA 
 
NCT Number:  
NCT04244370 
 
 
____________________________________________________ 
________________ 
Sponsor – Ryan Melloy, Associate Director, Clinical Affairs  
 
 
Date 
 
 
 
____________________________________________________ 
________________ 
Lead Principal Investigator – Dr. William Rilling  
 
 
Date 
 
 
This document contains information that is the confidential and proprietary property 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. Shred to dispose of document. 
 

Caterpillar™ Arterial Embolization Device 
MONARCH (BPV-18-001) Version 2 
Page 2 of 6 
 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
1. PROTOCOL SUMMARY 
Title: 
A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the 
Clinical Use of the Caterpillar™ Arterial Embolization Device for Arterial 
Embolization in the Peripheral Vasculature 
Sponsor: 
Bard Peripheral Vascular, Inc. 
1625 West 3rd Street 
Tempe, AZ 85281, USA 
Objectives: 
The primary objective of this study is to evaluate the performance and 
safety of the Caterpillar™ Arterial Embolization Device when used for 
arterial embolization in the peripheral vasculature in a real world, on-label 
application. 
Design: 
The post-market study is a prospective, multi-center, single-arm, real world 
study of the Caterpillar™ Arterial Embolization Device. Follow-up for all 
treated subjects will be performed at 30 days, as well as 6 and 12 months 
post-Index Procedure. 
Study Device: 
The Caterpillar™ Arterial Embolization Device (Caterpillar™ Micro and 
Caterpillar™) is a self-expanding arterial occlusion plug, intended for arterial 
embolization in the peripheral vasculature. The device is intended to be a 
permanent implant and consists of the following components: a cobalt-
chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker 
bands and a polyurethane and polyethylene occlusion membrane. 
  
The Caterpillar™ Arterial Embolization Device is packaged as a single unit 
with the implant, loader, dispenser hoop, detachable delivery wire and 
torque tool. The device is intended for single-use only within a specific 
arterial vessel size range and does not require oversizing. The available 
sizes, product characteristics, intended arterial vessel diameter range and 
required delivery catheter size (inner diameter (ID)) are provided in the 
Instructions for Use (IFU).   
Enrollment: 
Enrollment will continue until up to fifty (50) subjects have been treated with 
the Caterpillar™ Arterial Embolization Device. 
Study Sites: 
Up to 20 investigational sites in the United States. 
Study 
Population: 
Male or non-pregnant female subjects ≥18 years of age who require arterial 
embolization in the peripheral vasculature. 
Primary 
Endpoints: 
Primary Performance Endpoint: 
Technical Success 
Successful occlusion of the target embolization site(s) as confirmed by 
the Investigator via angiographic assessment during the Index 
Procedure. Technical success will be reported for each target 
embolization site.  
Primary Safety Endpoint: 
Freedom from Device-Related Serious Adverse Events (SAE) 
Freedom from device-related serious adverse events (SAE) through 
30-day follow-up. 

Caterpillar™ Arterial Embolization Device 
MONARCH (BPV-18-001) Version 2 
Page 3 of 6 
 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
Secondary 
Endpoints: 
Time Point of Occlusion 
The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, 
≤4, ≤5, ≤10 and >10 minutes post-treatment. 
Freedom from Recanalization 
Freedom from clinically relevant recanalization of the target embolization 
site(s) through 30-days, 6 and 12-months follow-up as confirmed by the 
Investigator. Clinically relevant recanalization is defined as recanalization 
through the study device that requires a re-intervention. Freedom from 
recanalization will be reported for each target embolization site. 
 
Freedom from Migration 
Freedom from Migration will be reported for each study device as follows: 
• Freedom from clinically relevant acute migration of the study 
device(s) as confirmed by the Investigator via angiographic 
assessment during the Index Procedure. Clinically relevant 
migration is defined as migration of the study device from the target 
embolization site that requires intervention. 
• Freedom from clinically relevant migration of the study device(s) 
through 30-days, 6 and 12-months follow-up as confirmed by the 
Investigator. Clinically relevant migration is defined as migration of 
the study device from the target embolization site that requires a re-
intervention.  
 
Freedom from Device and/or Procedure-Related Adverse Events 
Freedom from device and/or procedure-related adverse events (AE) 
through 30-days, 6 and 12-months follow-up. 
 
Accuracy of Delivery 
Accurate delivery of the study device to the target embolization site as 
assessed by the Investigator. 
 
Ease of Trackability/Deliverability 
Ease of study device trackability and deliverability as assessed by the 
Investigator. 
 
Ease of Detachment 
Ease of study device detachment as assessed by the Investigator. 
 
Acceptability of Visibility 
Acceptability of study device visibility under fluoroscopy as assessed by 
the Investigator. 

Caterpillar™ Arterial Embolization Device 
MONARCH (BPV-18-001) Version 2 
Page 4 of 6 
 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
Inclusion 
Criteria: 
Clinical Inclusion Criteria 
1. 
Subject or Legally Authorized Representative (LAR) must voluntarily 
sign and date the approved Informed Consent Form (ICF) prior to 
collection of study-specific data or performance of study-specific 
procedures. 
2. 
Subject must be either male or non-pregnant female ≥18 years of age 
with an expected lifespan sufficient to allow for collection of primary 
endpoint data. 
3. 
Subject must be willing and able to comply with protocol 
requirements, including all study visits and procedures. 
4. 
Subject must require peripheral vascular occlusion at an arterial 
target embolization site(s) that can be treated with the Caterpillar™ 
Arterial Embolization Device according to the Instructions for Use 
(IFU). Note: Per Investigator discretion, up to five (5) Target 
Embolization Sites may be treated with up to ten (10) study devices 
per subject. 
Angiographic Inclusion Criteria  
5. 
The target embolization site(s) must be located in a native arterial 
vessel(s) with the intended arterial vessel diameter ranges shown in 
the IFU, as assessed by the Investigator (via visual estimate). 
6. 
The target embolization site(s) must have a landing zone sufficient to 
accommodate the device implant lengths shown in the IFU. 
 
Exclusion 
Criteria: 
Clinical Exclusion Criteria 
1. 
The subject's access vessel(s) preclude safe insertion of the delivery 
catheter.  
2. 
The subject’s target embolization site(s) is located within a vein. 
3. 
The subject’s target embolization site(s) is located within the head, 
neck, heart or coronary vessels. 
4. 
The subject’s target embolization site(s) is located across highly 
locomotive joints or muscle beds (e.g. elbow, hip, knee, shoulder, 
thoracic inlet/outlet).  
5. 
The subject’s target embolization site(s) is located in a high-flow 
vessel where, in the opinion of the Investigator, there may be 
significant risk of migration and unintended (non-target site) 
occlusion. 
6. 
The subject has a known allergy or hypersensitivity to contrast media 
that cannot be adequately pre-medicated. 
7. 
The subject has a known allergy or hypersensitivity to any of the 
device materials including: cobalt, chromium, nickel, titanium, 
platinum, iridium, polyurethane or polyethylene. 
8. 
The subject has planned use of anticoagulant (e.g. direct thrombin 
inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet 
therapy before, during and/or after treatment with the study device, 

Caterpillar™ Arterial Embolization Device 
MONARCH (BPV-18-001) Version 2 
Page 5 of 6 
 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
which, in the opinion of the Investigator, would clinically interfere with 
the study endpoints. 
9. 
The subject has a known uncontrolled blood coagulation or bleeding 
disorder. 
10. 
The subject has an unresolved systemic infection. 
11. 
The subject’s required pre-operative laboratory tests and/or physical 
examination indicate abnormal results, which, in the opinion of the 
Investigator, would clinically interfere with the study endpoints. 
12. 
The subject has a connective tissue disorders (e.g. Ehlers-Danlos 
Syndrome), arteritis (e.g. Takayasu’s Disease) or another circulatory 
disorder, which, in the opinion of the Investigator, would clinically 
interfere with the study endpoints. 
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, may confound the data interpretation, or is associated with 
a life expectancy insufficient to allow for the collection of primary 
endpoint data. 
14. 
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. 
Procedures: 
All subjects will undergo an in-office clinical evaluation at the Screening 
Visit (prior to Index Procedure). Subjects that meet Eligibility Criteria will 
undergo additional in-office clinical evaluations and will be treated with the 
Caterpillar™ Arterial Embolization Device at the Index Procedure visit. An 
in-office follow-up visit or telephone contact will be performed at 30 days, 
as well as 6 and 12 months post-Index Procedure for all treated subjects. 
Principal 
Investigator: 
William S. Rilling, MD, FSIR 
Medical College of Wisconsin 
Division of Vascular and Interventional Radiology 
9200 W Wisconsin Ave 
Milwaukee, WI 53226, USA 
Medical 
Monitor: 
Daniel B. Brown, MD, FSIR 
Vanderbilt University Medical Center 
Department of Radiology 
1161 21st Avenue South 
Nashville, TN 37232, USA 
 
 
 
 

Caterpillar™ Arterial Embolization Device 
MONARCH (BPV-18-001) Version 2 
Page 6 of 6 
 
Bard Peripheral Vascular, Inc. 
TRADE SECRET/CONFIDENTIAL INFORMATION 
Notify BD Before Releasing this Document. 
 
2. STATISTICAL METHODS 
This section describes the planned statistical analyses for the study. A detailed Statistical Analysis 
Plan (SAP) will be developed that outlines the methodology used in the statistical analyses 
described below. 
 
2.1. Study Hypothesis 
There is no formal statistical hypothesis for this study. 
2.2. Sample Size Considerations 
The sample size is based on potential adequacy of data to meet the study objectives; it is not 
based on any statistical consideration. 
2.3. Data Analysis 
The analysis population consists of all subjects who have been treated with the study device 
as defined in Section 5.2.3. 
 
Data collected in this study will be summarized using descriptive statistics. Summary statistics 
will include frequency counts and percentages for categorical variables and mean, standard 
deviation, minimum, median, and maximum for continuous variables. 
• 
educed number of embolization devices required per procedure, potentially resulting 
in reduced procedural time and fluoroscopy exposure