CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
Conditions: Carotid Stenosis
Sponsor: Elutia Inc.



This document contains information that is confidential and proprietary.  The contents of this 
document may not be copied without written permission from the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORMATRIX® ECM® FOR CAROTID REPAIR  
FOLLOWING ENDARTERECTOMY REGISTRY 
 
 
 
 
PROTOCOL NUMBER:  11-PR-1021 
REVISION:  B 
 
 
 
 
SPONSOR: 
CORMATRIX CARDIOVASCULAR, INC. 
286 S. MAIN ST., SUITE 200 
ALPHARETTA, GA  30009 
 
 
 
 
DATE:  FEBRUARY 7, 2018 
 
 

CORMATRIX CARDIOVASCULAR, INC. 
PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
CONFIDENTIAL 
 
Sponsor Signature Page 
 
 
CORMATRIX® ECM® FOR CAROTID REPAIR  
FOLLOWING ENDARTERECTOMY REGISTRY  
 
 
 
PROTOCOL NUMBER:  11-PR-1021 
REVISION:  B 
 
 
SPONSOR: 
CORMATRIX CARDIOVASCULAR, INC. 
286 S. MAIN ST., SUITE 200 
ALPHARETTA, GA  30009 
 
 
 
 
 
 
 
 
 
 
 
 
DATE: FEBRUARY 7, 2018 
 
 
 
 
Robert Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular, Inc. 
 
 
Signature: __________________________________  Date: _____________________ 

CORMATRIX CARDIOVASCULAR, INC. 
PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
CONFIDENTIAL 
 
 
Investigator Signature Page 
 
 
CORMATRIX® ECM® FOR CAROTID REPAIR  
FOLLOWING ENDARTERECTOMY REGISTRY  
 
 
 
PROTOCOL NUMBER:  11-PR-1021 
REVISION:  B 
 
 
SPONSOR: 
CORMATRIX CARDIOVASCULAR, INC. 
286 S. MAIN ST., SUITE 200 
ALPHARETTA, GA  30009 
 
 
 
 
 
 
 
 
 
 
DATE: FEBRUARY 7, 2018 
 
 
 
 
Site Name:  
 
 
Print Investigator Name: ________________________________ 
 
Investigator Signature: __________________________________  Date: ______________ 
 
 
 

CORMATRIX CARDIOVASCULAR, INC. 
PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
CONFIDENTIAL 
TABLE OF CONTENTS 
 
EXECUTIVE SUMMARY ..........................................................................................................i 
REGISTRY CONTACTS ...........................................................................................................1 
REVISION HISTORY ...............................................................................................................1 
1.0  INTRODUCTION .............................................................................................................2 
1.1 BACKGROUND .......................................................................................................2 
1.2 DEVICE DESCRIPTION ...........................................................................................2 
1.3 REGULATORY STATUS ..........................................................................................2 
1.4 INDICATIONS FOR USE...........................................................................................3 
2.0  REGISTRY OBJECTIVES ................................................................................................3 
3.0  REGISTRY DESIGN ........................................................................................................3 
3.1 OUTCOME MEASURES ...........................................................................................3 
3.2 SAMPLE SIZE .........................................................................................................3 
3.3 REGISTRY DURATION/FOLLOW-UP .......................................................................3 
3.4 REGISTRY POPULATION AND ELIGIBILITY CRITERIA .............................................4 
3.5 PROCEDURAL OVERVIEW ......................................................................................4 
3.6 REGISTRY SITES ....................................................................................................4 
3.7 INSTITUTIONAL REVIEW BOARD APPROVALS .......................................................4 
3.8 REGISTRY CONDUCT .............................................................................................5 
4.0  SUBJECT ENROLLMENT INFORMATION .......................................................................5 
4.1 INFORMED CONSENT .............................................................................................5 
4.2 SURGEON TRAINING .............................................................................................5 
4.3 COVERAGE OF EXPENSES ......................................................................................5 
4.4 CONFIDENTIALITY ................................................................................................5 
5.0  DATA COLLECTION PROCEDURES ...............................................................................6 
5.1 PREOPERATIVE EVALUATION ................................................................................6 
5.2 OPERATIVE EVALUATION .....................................................................................6 
5.3 POSTOPERATIVE EVALUATION ..............................................................................6 
5.4 1 TO 3-MONTH FOLLOW-UP EVALUATION ............................................................6 
5.5 6-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) ..............................................6 
5.6 12-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) ............................................7 
5.7 24-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) ............................................7 
5.8 REGISTRY EXIT .....................................................................................................7 
5.9 DISCONTINUED SUBJECTS .....................................................................................7 
5.10 SUBJECTS LOST TO FOLLOW-UP ...........................................................................8 

CORMATRIX CARDIOVASCULAR, INC. 
PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
CONFIDENTIAL 
TABLE OF CONTENTS (CONT.) 
 
6.0  REPORTING OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ..........................8 
6.1 DEFINITIONS .........................................................................................................8 
6.2 REPORTING OF ADVERSE EVENTS .........................................................................9 
7.0  RISK/BENEFIT ASSESSMENT ........................................................................................11 
7.1 RISKS TO THE SUBJECT .........................................................................................11 
7.2 BENEFITS TO THE SUBJECT ....................................................................................11 
8.0  INVESTIGATOR RESPONSIBILITIES, RECORDS AND REPORTS.....................................11 
8.1 INVESTIGATOR RESPONSIBILITIES .........................................................................11 
8.2 INVESTIGATOR RECORDS ......................................................................................12 
8.3 INVESTIGATOR REPORT.........................................................................................12 
9.0  MONITORING ................................................................................................................13 
10.0  SPONSOR RESPONSIBILITIES AND RECORDS ...............................................................14 
10.1 MODIFICATION OF PROTOCOL ...............................................................................14 
10.2 PREMATURE TERMINATION OF REGISTRY .............................................................14 
10.3 SERIOUS ADVERSE EVENT REPORTING .................................................................14 
10.4 SPONSOR RECORDS ...............................................................................................14 
11.0 DATA MANAGEMENT/DATA ANALYSIS/FINAL REPORT ..............................................15 
11.1 DATA MANAGEMENT ............................................................................................15 
11.2 DATA ANALYSIS ...................................................................................................15 
11.3 FINAL REPORT ......................................................................................................16 
 
 
ATTACHMENTS 
ATTACHMENT 1: 
EXAMPLE OF INFORMED CONSENT FORM 
ATTACHMENT 2: 
CORMATRIX ECM FOR CAROTID REPAIR IFU 
ATTACHMENT 3: 
DRAFT CASE REPORT FORMS 
 

CORMATRIX CARDIOVASCULAR, INC. 
PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
i 
CONFIDENTIAL 
EXECUTIVE SUMMARY 
 
TITLE OF REGISTRY: 
CorMatrix® ECM® for Carotid Repair Following 
Endarterectomy Registry 
PROTOCOL NUMBER: 
11-PR-1021 
OBJECTIVES: 
To capture and assess device performance data from 
subjects undergoing patch angioplasty of the carotid artery 
following carotid endarterectomy using the CorMatrix 
ECM for Carotid Repair per its FDA cleared Indications 
for Use. 
To provide an ongoing post-market surveillance 
mechanism to document clinical outcomes on the use of 
the CorMatrix ECM for Carotid Repair. 
REGISTRY DESIGN: 
A multi-center, prospective, single-arm, post-market, 
observational registry of subjects receiving the CorMatrix 
ECM for Repair for patch angioplasty following carotid 
endarterectomy (CEA) procedures. 
ENROLLMENT: 
Up to 230 subjects may be enrolled from up to ten U.S. 
clinical sites. 
INCLUSION CRITERIA: 
Subjects must be undergoing carotid endarterectomy with 
patch angioplasty closure. 
Subject’s operative surgeon intends to use CorMatrix 
ECM as the patch material for closure of the carotid artery 
per its FDA cleared Indications for Use. 
The subject must possess the ability to provide written 
Informed Consent. 
The subject must express an understanding and 
willingness to fulfill all of the expected requirements of 
this clinical protocol. 
EXCLUSION CRITERIA: 
Subjects with a known sensitivity to porcine material. 
REGISTRY PROCEDURES: 
Baseline clinical evaluation and standard follow-up 
evaluations, including carotid duplex imaging, at 1 to 3-
months, 6-months, 12-months, and 24-months 
postprocedure. Follow-up data will be collected and 
entered by site personnel in SUGAR COMMUNITY 
EDITION, electronic data capture system. 
OUTCOME MEASURES: 
Carotid procedure and device related adverse events to 
determine device performance data will be collected. 
STATISTICAL ANALYSIS: 
Descriptive analyses will include overall subject 
characteristics and outcomes. 

CORMATRIX CARDIOVASCULAR, INC. 
 
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PROTOCOL NUMBER:  11-PR-1021/REVISION B 
 
CONFIDENTIAL 
 
REGISTRY CONTACTS 
SPONSOR 
 
CorMatrix Cardiovascular, Inc. 
Rhonda Van Genderen 
286 S. Main St., Suite 200 
Alpharetta, GA  30009 
 
Cell:  715-441-5411  
Email:  rvangenderen@cormatrix.com 
FAX: 1-800-861-8179 
 Telephone:  678-566-2628 
 
 
 
 
REVISION HISTORY 
REVISION 
DESCRIPTION OF CHANGE 
REVISION A 
JANUARY 24, 2012 
INITIAL RELEASE 
REVISION B 
FEBRUARY 7, 2018 
PROVIDED INFORMATION ON ELECTRONIC 
DATA CAPTURE 

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1.0 
INTRODUCTION 
1.1 
BACKGROUND  
Ischemic stroke caused by carotid artery atherosclerosis constitutes major 
morbidity, mortality, and health care expenditure. Carotid endarterectomy 
(CEA) is performed to remove atherosclerotic plaque and reduce stroke 
risk. CEA has been studied extensively within the context of the patient’s 
symptomatic status and degree of carotid stenosis, or narrowing. It has 
been shown to reduce longer-term risks of stroke in patients without 
neurologic symptoms and those with prior transient ischemic attacks 
(TIA) and non-disabling stroke (ACAS/ECST/NASCET/ACST) who have 
hemodynamically significant carotid stenosis. As such a studied 
procedure, technical aspects of its performance have been scrutinized. 
After the endarterectomy portion of the procedure is performed, the 
arteriotomy must be closed. This can be done by primary closure using 
suture to reapproximate the longitudinal artery opening, or with a patch. 
This is known as “patch angioplasty.” Patch angioplasty has evolved over 
time, and it is now widely accepted that use of a patch for closure 
significantly reduces the risks of carotid restenosis, stroke, and death.1 
There are several materials, which have been utilized for patch closure 
after CEA. These include autogenous saphenous vein, cervical veins, 
glutaraldehyde-treated bovine pericardium, and synthetic materials (i.e., 
ePTFE, Dacron, etc.). However, currently available synthetic or 
chemically treated patch materials may induce scar tissue formation 
leading to restenosis and can lead to a higher risk of infection.2  The 
CorMatrix ECM for Carotid Repair is an attractive vascular patch material 
due to its ability to be remodeled into healthy native tissue.  
1.2 
DEVICE DESCRIPTION 
The CorMatrix ECM for Carotid Repair is an acellular, natural collagen 
construct, derived from the porcine small intestine submucosa that has 
demonstrated the ability to provide a scaffold for cells for remodeling 
various tissues following implantation into subjects.   
The CorMatrix ECM for Carotid Repair is supplied in a six-ply sheet, 
which can be cut to size as the physician deems necessary for the specific 
procedure to be performed.  The CorMatrix ECM for Carotid Repair is 
provided in a lyophilized, sterile state and is for single use only. 
1.3 
REGULATORY STATUS 
CorMatrix Cardiovascular, Inc. received U.S. FDA 510(k) premarket  
                                          
1  Awad IA and Little JR. Patch angioplasty in carotid endarterectomy. Advantages, concerns, and 
controversies. Stroke 1989;20;417-22. 
2  Bond R et al. Systematic review of randomized controlled trials of patch angioplasty versus primary closure 
and different types of patch materials during carotid endarterectomy. J Vasc Surg 2004;40:1126-35. 

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clearance (K111187) for the CorMatrix ECM for Carotid Repair on      
July 26, 2011.   
1.4 
INDICATIONS FOR USE 
The CorMatrix ECM for Carotid Repair is intended for use as a patch 
material for vascular reconstruction and repair of the carotid artery, 
including patch closure following carotid endarterectomy and suture line 
buttressing. 
2.0 
REGISTRY OBJECTIVES 
The objective of this registry is to capture and assess device performance data 
from subjects undergoing patch angioplasty of the carotid artery following carotid 
endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared 
Indications for Use.  This registry provides an ongoing post-market surveillance 
mechanism to document clinical outcomes on the use of the CorMatrix ECM for 
Carotid Repair. 
3.0 
REGISTRY DESIGN 
This is a multi-center, prospective, single-arm, post-market, observational registry 
of subjects receiving the CorMatrix ECM for Carotid Repair for patch angioplasty 
following carotid endarterectomy procedures. 
This post-market registry may involve up to ten U.S. clinical sites and up to 230 
subjects.  Data will be collected through the 24-month follow-up.  The data may 
also be used for publications.  
3.1 
OUTCOME MEASURES 
3.1.1 Performance:  Observe the performance and clinical outcome of 
the CorMatrix ECM for Carotid Repair for patch angioplasty 
following carotid endarterectomy. Collected data will include both 
carotid procedure and device related adverse events to determine 
device performance data. 
3.2 
SAMPLE SIZE 
Up to 230 subjects may be enrolled in this registry. 
3.3 
REGISTRY DURATION/FOLLOW-UP 
All subjects enrolled in this registry will be evaluated preoperatively and 
followed from their treatment date through 24-months postprocedure. 
Subjects will have a baseline standard clinical evaluation and standard 
follow-up evaluations, including carotid duplex imaging, at 1 to 3-months, 
6-months, 12-months, and 24-months postprocedure. If intraoperative 
completion duplex or other imaging (i.e., CTA, MRA, arteriography) is 
performed, data should be collected, but this is not mandatory. 

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3.4 
REGISTRY POPULATION AND ELIGIBILITY CRITERIA 
Subjects must meet the following requirements in order to be eligible for 
enrollment in the registry: 
3.4.1 Inclusion Criteria 
All subjects are required to meet the following inclusion criteria in 
order to be considered eligible for participation in this registry: 
• Subjects must be undergoing carotid endarterectomy with 
patch angioplasty closure. 
• Subject’s operative surgeon intends to use CorMatrix ECM 
as the patch material for closure of the carotid artery per its 
FDA cleared Indications for Use. 
• The subject must possess the ability to provide written 
Informed Consent. 
• The subject must express an understanding and willingness 
to fulfill all of the expected requirements of this clinical 
protocol. 
3.4.2 Exclusion Criteria 
Subjects will be excluded from participating in this registry if the 
following exclusion criterion is met: 
• Known sensitivities to porcine material 
3.5 
PROCEDURAL OVERVIEW 
After a subject has undergone the preoperative evaluation, has been 
determined to be eligible for the registry and signed an Informed Consent 
Form, he or she will be considered enrolled in the registry.  After 
enrollment, the subject will undergo a standard carotid interventional 
procedure including carotid endarterectomy.  The subject’s carotid 
arteriotomy site will be closed using the CorMatrix ECM for Carotid 
Repair.  The surgeon will implant the CorMatrix ECM for Carotid Repair 
according to the FDA cleared Instructions for Use. 
3.6 
REGISTRY SITES 
Up to ten U.S. clinical sites may participate. Sites will be selected due to 
ability to provide expertise in carotid endarterectomy and carotid duplex 
imaging. 
3.7 
INSTITUTIONAL REVIEW BOARD APPROVALS 
Before any subject can be enrolled in this registry, the Institutional Review 
Board (IRB) for the specific institution must approve the protocol and the 
Informed Consent Form to be used at that site.  A subject cannot be asked 

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to sign the Informed Consent Form until the registry has been fully 
approved by the institution’s IRB.  The Sponsor will require a copy of any 
IRB correspondence, as well as the final approval letter and the final 
approved Informed Consent Form, from each IRB. 
3.8 
REGISTRY CONDUCT 
This registry will be performed in accordance with Title 21 Code of 
Federal Regulations Parts 50 and 56 and other relevant FDA regulations 
and the relevant sections of the ICH Guidelines for Good Clinical 
Practices. 
The principles of the Declaration of Helsinki have been addressed in the 
design of the registry, consideration of the risk and benefits to the subjects, 
selection of the site and Investigators to conduct the registry, measures 
taken to protect the health and rights of the human subjects, and 
registration of the registry in a publicly accessible database. 
4.0 
SUBJECT ENROLLMENT INFORMATION 
4.1 
INFORMED CONSENT 
Subjects cannot be asked to sign the Informed Consent Form until the 
registry has been fully approved by the respective institution’s IRB and 
the Sponsor has received and reviewed the specific IRB approved 
Informed Consent Form.  When the Investigator has determined the 
eligibility of a specific subject to enter the registry, the Informed Consent 
Form must be completed.  The Informed Consent Form must be read by 
the subject, the subject’s questions answered and the form signed and 
dated by the subject, before the surgical procedure can be performed.  All 
subjects are to receive copies of their Informed Consent Form. 
4.2 
SURGEON TRAINING 
Surgeons will be trained prior to subject enrollment by CorMatrix 
personnel according to the FDA cleared CorMatrix ECM for Carotid 
Repair Instructions for Use. 
4.3 
COVERAGE OF EXPENSES 
Subjects will not be reimbursed or compensated for participating in the 
registry; the procedure will be billed to medical insurance as per standard 
procedure. 
4.4 
CONFIDENTIALITY 
Confidentiality of subjects will be maintained throughout the registry.  A 
unique identification code will be assigned to each subject participating in 
this registry.  Any data that may be published in abstracts, scientific 
journals, or presented at medical meetings will reference a unique subject 
code and will not reveal the subject’s identity.  The Sponsor will make 

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every reasonable effort to protect the confidentiality of the subjects 
participating in the registry. 
5.0 
DATA COLLECTION PROCEDURES 
5.1 
PREOPERATIVE EVALUATION 
The following information will be collected for each subject: 
demographics, risk factors, preoperative medications (anti-platelets, anti-
coagulants, anti-arrhythmics, anti-hypertensives, betablockers, and statins) 
taken within approximately 3 months prior to the procedure and 
verification that the subject meets inclusion/exclusion criteria specified in 
the protocol.  A carotid duplex imaging or approved testing is required 
preoperatively (within 60 days of the procedure) to measure the 
percentage of carotid artery stenosis.   
5.2 
OPERATIVE EVALUATION 
The carotid endarterectomy should be performed per the surgeon and 
institution’s standard CEA procedures.  Specific data on the CEA 
procedure as well as the CorMatrix ECM will be collected.  Also, carotid 
procedure and/or device related adverse events will be documented on 
appropriate CRFs in SUGAR COMMUNITY EDITION, electronic data 
capture system. 
5.3 
POSTOPERATIVE EVALUATION 
Postoperative data from the end of the CEA procedure until the subject is 
discharged from the hospital will be collected.  Medications (anti-platelets, 
anti-coagulants, anti-arrhythmics, anti-hypertensives, betablockers, and 
statins) and carotid procedure and/or device related adverse events will be 
documented on appropriate CRFs in SUGAR COMMUNITY EDITION, 
electronic data capture system. 
 
5.4 
1 TO 3-MONTH FOLLOW-UP EVALUATION 
Subjects will have a follow-up evaluation at 1 to 3 months after the carotid 
procedure.  Information will be collected regarding the subject’s health 
status, medications (anti-platelets, anti-coagulants, anti-arrhythmics, anti-
hypertensives, betablockers, and statins) and the occurrence of any carotid 
and/or device related adverse events.  A carotid duplex imaging or 
approved testing is required and the data will be collected on appropriate 
CRFs in SUGAR COMMUNITY EDITION, electronic data capture 
system. Results of any additional anatomic imaging performed should be 
recorded. 
5.5 
6-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) 

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Subjects will have a follow-up evaluation 6 months (± 1 month) after the 
carotid procedure.  Information will be collected regarding the subject’s 
health status, medications (anti-platelets, anti-coagulants, anti-
arrhythmics, anti-hypertensives, betablockers, and statins) and the 
occurrence of any carotid and/or device related adverse events. A carotid 
duplex imaging or approved testing is required and the data will be 
collected on appropriate CRFs in SUGAR COMMUNITY EDITION, 
electronic data capture system.  Results of any additional anatomic 
imaging performed should be recorded. 
5.6 
12-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) 
Subjects will have a follow-up evaluation 12 months (± 1 month) after the 
carotid procedure.  Information will be collected regarding the subject’s 
health status, medications (anti-platelets, anti-coagulants, anti-
arrhythmics, anti-hypertensives, betablockers, and statins) and the 
occurrence of any carotid and/or device related adverse events. A carotid 
duplex imaging or approved testing is required and the data will be 
collected on appropriate CRFs in SUGAR COMMUNITY EDITION, 
electronic data capture system.  Results of any additional anatomic 
imaging performed should be recorded. 
5.7 
24-MONTH FOLLOW-UP EVALUATION (± 1 MONTH) 
Subjects will have a follow-up evaluation 24 months (± 1 month) after the 
carotid procedure.  Information will be collected regarding the subject’s 
health status, medications (anti-platelets, anti-coagulants, anti-
arrhythmics, anti-hypertensives, betablockers, and statins) and the 
occurrence of any carotid and/or device related adverse events. A carotid 
duplex imaging or approved testing is required and the data will be 
collected on appropriate CRFs in SUGAR COMMUNITY EDITION, 
electronic data capture system.  Results of any additional anatomic 
imaging performed should be recorded. 
5.8 
REGISTRY EXIT 
Subjects will be exited from the registry following their scheduled 24-
month follow-up evaluation, or earlier if the subject withdraws from the 
registry, or his/her participation is discontinued by the Investigator, or 
death.  The date each subject completed the registry per this protocol, or if 
not, then the date the subject exited from the registry and the primary 
reason should be recorded.  Any subject who experiences a serious carotid 
and/or device related adverse event that is ongoing at the time of exit will 
be followed by the physician until the adverse event is resolved or the 
subject is medically stable in the opinion of the Investigator.  
5.9 
DISCONTINUED SUBJECTS 

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Subjects are considered enrolled once they have signed the informed 
consent form.  There are three categories of discontinued subjects: those 
who withdraw from the registry prior to any activities related to the 
treatment procedure; those in whom implantation of the CorMatrix ECM 
for Carotid Repair does not occur due to clinical concerns at the time of 
operation; and those who elect to withdraw from the registry after 
implantation of the CorMatrix ECM device.  Discontinued subjects will be 
followed by the physician until they are considered to be medically stable.  
5.10 
SUBJECTS LOST TO FOLLOW-UP 
If the Investigator or study coordinator has attempted to contact a subject 
at least three times within 60 days and received no response, the subject 
may be considered lost to follow-up.  The Investigator or study 
coordinator will document the minimum of three attempts to contact the 
subject, including sending a certified letter, and contacting the Sponsor, 
prior to terminating the subject from the registry. 
6.0 
REPORTING OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
6.1 
DEFINITIONS 
An “Adverse Event” (AE) is any clinical finding that is an undesired or 
pathological change in a registry subject as indicated by signs, symptoms, 
illnesses and events that develop or worsen in severity in association with 
the registry whether or not thought to be related to the device or 
procedure.  Adverse events include current illness, injuries, side effects, 
toxicities, allergic reactions, or events that occur or worsen during the 
course of a clinical study. This registry will only collect carotid procedure 
and device related adverse events as well as any carotid related clinical 
findings. 
Adverse Events will be classified as Serious Adverse Events (SAEs) if the 
event: 
• 
is life threatening (even if temporary in nature) or fatal; 
• 
results in permanent impairment of a body function or permanent 
damage to a body structure; 
• 
requires medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body 
structure; or 
• 
requires or prolongs hospitalization. 
Once a clinical finding is noted, and the finding is classified as an AE or 
SAE, the relationship to the device will be classified as follows: 
• 
Not Related:  The event is due to an underlying or concurrent 
illness or effect of another device, drug or intervention and is not 
related to the use of the registry device. 

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• 
Possible:  The event has a strong temporal relationship to the use 
of the registry device, and an alternative etiology is equally or less 
likely. 
• 
Probable:  The event has a strong temporal relationship to the use 
of the registry device, and another etiology is unlikely or 
significantly less likely. 
• 
Definite:  An event that can only be attributed to the use of the 
registry device. 
If a SAE is determined to be probably or definitely related to the device 
and has not been previously anticipated, the clinical finding would be 
classified as an unanticipated adverse device effect (UADE).  An UADE is 
defined as “any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a device, if 
that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, 
or welfare of subjects.” 
SAEs that are determined to be probably or definitely related to the study 
device are referred to as device related serious adverse events (DRSAEs).   
The protocol definitions for “device failure” and “device malfunction” and 
“technical observation” are provided below: 
• 
Device Failure:  A device has failed if it does not perform 
according to the Instructions for Use or other labeling provided 
with the device and, as a result, negatively impacts the treatment 
when used according to this protocol. 
• 
Device Malfunction:  A device malfunction is an unexpected 
change to the device that is not contradictory to the labeling and 
may or may not affect the performance of the device. 
• 
Technical Observation:  Malfunction or complaint with a medical 
device that has the potential to, but may or may not, result in a 
negative clinical consequence to the subject. 
Note:  A device failure or device malfunction is considered to be a 
DRSAE if it causes or contributes to a SAE. 
6.2 
REPORTING OF ADVERSE EVENTS 
Carotid procedure and device related adverse events are to be completed at 
any point from the time the subject is enrolled to the time of exit from the 
registry.  Adverse events are to include carotid procedure and device 
related adverse events as well as any carotid related clinical findings. 
Registry subjects will be instructed to immediately report to the 
Investigator any carotid related unusual signs or symptoms.  The 

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Investigator will take whatever means are necessary to treat the subject, 
should an adverse event occur.  First consideration will be given to the 
welfare of the subject rather than the successful completion of the registry.  
All subjects experiencing a carotid procedure and/or device related 
adverse event will be followed until their clinical outcome is determined, 
if at all possible, or until completion of the last follow-up visit, whichever 
occurs later. 
All carotid procedure and/or device related findings must be recorded on 
the appropriate CRF in SUGAR COMMUNITY EDITION, electronic 
data capture system.  A description of the finding, including the start date, 
resolution date, action taken, and the outcome should be provided, along 
with the Investigator’s assessment of the relationship between the finding 
and the device.  Subjects’ complaints of any carotid related symptoms that 
are outside the normal pattern for the illness treated should be considered 
AEs. 
All carotid procedure and/or device related AE’s shall be followed until 
the event is resolved or determined by the Investigator to be stable.  The 
investigational site will provide relevant follow-up information to the 
Sponsor upon request.   
All SAEs and UADEs must be immediately reported to the Sponsor, 
CorMatrix Cardiovascular, via telephone or e-mail within 24 hours of the 
Investigator becoming aware of the event.  A completed “Serious Adverse 
Event” form must be faxed or express mailed to the Sponsor within five 
working days of the event.  The minimum required data to be recorded for 
an SAE includes: date of event, type of event, actions taken, outcome and, 
if appropriate, causality and possible relationship to the device(s) used in 
this registry.  In the case of a DRSAE, when possible, the device involved 
in the failure or malfunction is to be made available to the Sponsor for 
analysis. 
If a serious adverse event is being reported after normal working hours, 
the Investigator will leave a voice message at one of the following 
telephone numbers with accompanying report of the adverse event sent to 
the fax number(s) below: 
Sponsor: 
CorMatrix Cardiovascular, Inc. 
Rhonda Van Genderen 
286 S. Main St., Suite 200 
Alpharetta, GA  30009 
 
Cell:  715-441-5411  
Email:  rvangenderen@cormatrix.com 
FAX:  1-800-861-8179 
Telephone:  678-566-2628 
 

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The IRB will be notified of serious adverse events per the specific IRB’s 
reporting requirements.  The IRB will be informed if, in the opinion of the 
Sponsor or the Investigator, the serious adverse event is likely to affect the 
safety of the subjects or the conduct of this registry. 
Follow-up reports will be filed using the Adverse Event CRF in SUGAR 
COMMUNITY EDITION, electronic data capture system as new 
information is available or there is a change in the subject’s condition. 
 
7.0 
RISK/BENEFIT ASSESSMENT 
7.1 
RISKS TO THE SUBJECT 
The possible risks associated with the use of the CorMatrix ECM for 
Carotid Repair for patch angioplasty after CEA are similar to the risks 
associated with other patch materials for reconstruction or repair of the 
carotid artery.  Risks associated with the use of the CorMatrix ECM for 
Carotid Repair include: 
• Acute or chronic inflammation (Initial application of the 
CorMatrix ECM may be associated with transient, mild, localized 
inflammation) 
• Allergic reaction 
• Bleeding 
• Embolization of ECM 
• Infection 
• Patch dehiscence 
• Pseudoaneurysm 
• Recurrent stenosis 
• Stroke 
• Thrombosis 
• Vessel occlusion 
The known precautions and warnings are listed in the IFU, included as 
Attachment 2. 
7.2 
BENEFITS TO THE SUBJECT 
The benefits of the CorMatrix ECM for Carotid Repair used for patch 
angioplasty after CEA have not been established by previous clinical 
studies.   
Subjects participating in this registry may not receive immediate benefit; 
however, feedback from this registry will provide valuable information 
that may benefit subjects in the future. 
8.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS AND REPORTS 

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8.1 
INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for ensuring that this registry is conducted 
according to this protocol and that the signed Informed Consent Form is 
obtained from each subject prior to their inclusion in this registry. 
It is the Investigator’s responsibility to ensure that all staff assisting with 
this registry have the appropriate qualifications and are fully instructed on 
the registry procedures and respect subject confidentiality, as specified in 
the Investigator Agreement and Financial Disclosure. All participating 
Investigators are required to sign an Investigator Agreement and Financial 
Disclosure form prior to their participation. 
The Investigator is responsible for ensuring that the conduct of the registry 
conforms to the IRB requirements and provides all necessary 
communication with the IRB including, but not limited to, annual study 
reports and required adverse event notifications. 
8.2 
INVESTIGATOR RECORDS 
Source documentation and standardized Case Report Forms (CRFs) in 
SUGAR COMMUNITY EDITION, electronic data capture system will be 
used to collect complete and accurate records of the clinical data from the 
registry according to the Good Clinical Practices (GCP) requirements.  
The Investigator is responsible for collecting and accurately recording the 
data generated for this registry. 
The Investigator is responsible for ensuring the maintenance of complete, 
accurate and current records including the following materials: 
• All correspondence with the Sponsor and the IRB; 
• Subject records, including signed Informed Consent Forms for all 
enrolled subjects, and all supporting source documents (laboratory 
reports and reports of diagnostic tests, medical records, etc.) and 
operative records for each subject; 
• The representative copy of the IFU provided with the CorMatrix 
ECM for Carotid Repair utilized in this registry; 
• A copy of the approved protocol for this registry and all 
subsequent revisions to the protocol; 
• A description of any protocol deviation(s) and the justification for 
the deviation(s); 
• Copies of carotid procedure or device related adverse events, 
device failure/malfunction or Medical Device Reports (MDR) 
submitted; and 
• A copy of the approval letter from the respective Investigational 
Review Board (IRB), with the names of the participating members 
of the IRB, the approved informed consent (and any subsequent 

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revisions) and any specific IRB follow-up or reporting 
requirements to be addressed during the registry. 
8.3 
INVESTIGATOR REPORT 
The Investigator will be responsible for providing the following reports to 
the Sponsor for this registry: 
8.3.1 Serious Adverse Event 
Serious Adverse Events are defined in Section 6.1, and the 
required reporting timeline and appropriate contacts are 
outlined in Section 6.2.  The Investigator is responsible for 
reporting all events within the designated timeline and for 
maintaining initial reports and any follow-up reports that may 
be completed during the registry.  All follow-up reports must 
also be sent to the Sponsor within five working days of the 
follow-up report being necessary due to new information or a 
change in the subject’s status. 
8.3.2 Withdrawal of Approval 
If the IRB withdraws the approval to conduct the registry for any 
reason, the Investigator should notify the Sponsor as soon as 
possible and no later than five working days after the withdrawal 
of the approval. 
8.3.3 Deviations from the Investigational Plan 
The Investigator must notify the Sponsor and the reviewing IRB of 
any deviation from the Investigational Plan to protect the life or 
physical well being of a subject in the case of an emergency.  This 
notice must occur as soon as possible, but in no case longer than 
five working days after the deviation has occurred.  Subjects who 
do not meet the inclusion/exclusion criteria for the registry may not 
be enrolled as a deviation; any deviations from the enrollment 
criteria must receive prior approval from the Sponsor and IRB. 
Subject visits outside of window will not require a five day 
notification, but should be reported promptly as a deviation. 
8.3.4 Use of Information and Publication 
It is intended that the results of the registry may be published in the 
scientific literature and/or presented at scientific meetings (without 
disclosing the identity of the subjects in the written data or 
photographs).  Results may also be used in submissions to 
regulatory authorities.  Specific information regarding confidential 
information, and the collaboration and prior review of any planned 
publication activities (including presentations) is covered in the 
separate documentation between the Sponsor and Investigator. 

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9.0 
MONITORING 
Study monitors qualified by training and experience, will be responsible for monitoring 
and overseeing the conduct of the registry. The study monitors may evaluate compliance 
with the protocol, FDA regulations, any specific recommendations made by the site’s 
IRB and the signed Investigator Agreement.  Phone contacts and site visits may be 
conducted to ensure that the protocol is being followed and that any protocol deviations 
are properly documented. The Investigator will make available to the study monitor for 
review all Informed Consent Forms, all completed CRFs in SUGAR COMMUNITY 
EDITION, electronic data capture system, source documentation and other relevant 
records for all enrolled subjects at the site.  It is important that the Investigator and other 
relevant site personnel are available for consultation with the study monitors during the 
monitoring visits and that sufficient time is devoted at the site to the monitoring process. 
If a deficiency is noted during an on-site visit (or at any other time during the course of 
the registry), the study monitor is required to discuss the situation with the Investigator 
and the Sponsor (if required) to secure compliance. 
10.0 
SPONSOR RESPONSIBILITIES AND RECORDS 
10.1 
Modification of Protocol 
Any amendment to this protocol must be signed and dated by the Sponsor 
and the Investigator prior to its implementation.  In the event the 
modification has the potential to impact the scientific soundness of the 
investigational plan or the rights, safety, or welfare of the human subjects 
involved in the investigation, the modification also will require IRB 
approval prior to its implementation.  Any changes to the investigational 
plan that affects the rights, safety and welfare of the human subjects will 
most likely require a modification of the informed consent.  Any changes 
to the informed consent will also require IRB approval prior to 
implementation, and may require subjects already enrolled in the registry 
to sign a new informed consent. 
10.2 
Premature Termination of Registry 
The registry may be terminated at any time in the event of the occurrence 
of serious or unexpected adverse events that are determined by the 
Sponsor or the Investigator to pose a significant safety concern.  In 
addition, the registry may be terminated at any time in the event of the 
occurrence of information that indicates that the device will not be 
commercially viable, or in the event that the Sponsor can no longer fund 
the registry. 
The Sponsor will notify the Investigator in the event of premature 
termination of the registry.  Further registry enrollment will be terminated 
at that time.  Follow-up visits will continue for all enrolled subjects to 
ensure their safety.  All subjects experiencing adverse events will be 
followed to resolution or until they are considered to be medically stable 
by the Investigator. 

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10.3 
Serious Adverse Event Reporting 
All carotid procedure and device related serious adverse events that are 
associated with the use of the device will be evaluated in accordance with 
the protocol and the Sponsor’s Incident/Event Reporting SOP.  Any 
serious adverse event that requires a Medical Device Report will be 
reported by the Sponsor to FDA in accordance with the Sponsor’s Medical 
Device Reporting SOP. 
10.4 
Sponsor Records 
The Sponsor shall maintain complete, accurate and current records for the 
registry, including the following materials: 
• Copies of the approved registry protocol and any revisions; 
• All correspondence with the Investigator and site personnel, and 
the IRB; 
• Site information including address and IRB information; 
• Investigators’ curriculum vitae; 
• Registry records including copies of IRB submissions and 
approvals for the registry, IRB approved consent forms and any 
modifications (and associated approvals); 
• Receipt and maintenance of all data as collected on CRFs in 
SUGAR COMMUNITY EDITION, electronic data capture 
system.for the registry; 
• Reports of device malfunctions and failures; and 
• Reports of carotid procedure or device related adverse events, 
including SAEs, DRSAEs and UADEs. 
11.0 
DATA MANAGEMENT/DATA ANALYSIS/FINAL REPORT 
11.1 
DATA MANAGEMENT  
The Investigator is responsible for the accurate completion and timely 
submission of the data collected during this registry.  All data from this 
registry will be entered in SUGAR COMMUNITY EDITION, electronic 
data capture system. Data will be frequently reviewed to identify 
inconsistent or missing data and any carotid related adverse events.  Any 
data issues are to be promptly addressed with the Investigator by the 
Sponsor or designated representative.  Clinical procedures will be 
established to ensure that complete, accurate and timely data are 
submitted, that protocol requirements are followed and that carotid 
procedure or device related serious adverse events are correctly reported 
and investigated, as appropriate.  The Investigator is to maintain all source 
documents as required by the protocol, including laboratory results, 
supporting medical records, and signed Informed Consent forms. 

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11.2 
DATA ANALYSIS 
For continuous variables such as subject age, the mean, standard 
deviation, median and range will be presented.  For categorical variables 
such as presence of conditions observed under medical history, the 
number experiencing the condition over the total number completing the 
registry, the percentage, and the exact 95% confidence interval on the 
percentage will be presented. 
Carotid procedure and device related serious adverse events will be listed 
and the time course, outcome, severity and possible relationship to the 
device will be documented. 
Time to event analysis, when deemed necessary, will be performed using 
Kaplan Meier methods with any comparisons done via log-rank testing. 
11.3 
FINAL REPORT 
A final report will be prepared by the Sponsor at the conclusion of this 
registry which will summarize all of the data collected, the parameters of 
all treatments and all carotid procedure and device related serious adverse 
events recorded during the registry.  Copies of the final report will be 
provided to the Investigator and IRB.