A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
Conditions: Cardiovascular Disease
Sponsor: Elutia Inc.

 
Protocol 14-PR-1110D                                                                                                            2 
 
 
 
SECURE STUDY 
 
A POST MARKET OBSERVATIONAL STUDY TO OBTAIN ADDITIONAL 
INFORMATION ON THE USE OF CANGAROO ECM® ENVELOPE  
 
 
STUDY SPONSOR: 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 
PROTOCOL NUMBER: 14-PR-1110 
REVISION:  D 
 
FEBRUARY 7, 2018 
 
 
 
 
   
 
Please Note:  Confidential information contained herein is made available 
to you in your capacity as Investigator, Medical Advisor, or Consultant 
to Aziyo Biologics, Inc.  It is provided only for review by you, your staff, 
IRB/Ethics Committee members, or other regulatory authority.  Except as 
necessary to obtain properly informed consent for participation, it is 
expected that there will be no disclosure to other persons. 
 
Investigator Statement of Compliance 
I hereby agree to comply with this protocol and applicable regulations 
governing clinical trials, including local regulations, and Good Clinical 
Practice / ICH Guidelines. 
 
 
 
Investigator Signature: ___________________________________________                                           
 
Date: _________________________________________________________ 
 
 

 
Protocol 14-PR-1110D                                                                                                            3 
 
Summary of Revisions October 20, 2017 
Rationale 
Changed CorMatrix to Aziyo throughout 
document where applicable 
Change made to correct change in ownership 
of company 
Updated Sponsor Address 
To reflect current address 
Section 9:  Added additional study visit 
To capture AE and infection information at 
later time point. 
Investigator Obligations 
Updated to allow for trained study staff to 
conduct IC and other duties, as applicable. 
Summary of Revision February 7, 2018 
 
Added information on Clindex, electronic 
data capture software 
To provide additional  information on data 
collection  
 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            4 
 
Table of Contents   
STUDY COORDINATION........................................................................................................................ 5 
STUDY SYNOPSIS .................................................................................................................................... 6 
1. 
INTRODUCTION AND RATIONALE ........................................................................................... 7 
4. 
PRIOR CLINICAL EVALUATIONS .............................................................................................. 8 
5. 
STUDY OBJECTIVES .................................................................................................................... 10 
6. 
STUDY DESIGN .............................................................................................................................. 10 
7. 
STUDY POPULATION ................................................................................................................... 10 
8. 
STUDY METHODS ......................................................................................................................... 10 
9. 
STUDY PROCEDURES .................................................................................................................. 11 
10. ADVERSE EVENT REPORTING ................................................................................................. 11 
10.1 DEFINITIONS ................................................................................................................................................ 11 
10.2 ASSESSING AND RECORDING ADVERSE EVENTS .......................................................................................... 12 
10.3 POSSIBLE ADVERSE EVENTS ....................................................................................................................... 13 
11. DATA ANALYSIS ........................................................................................................................... 13 
12.  ETHICAL CONSIDERATIONS .................................................................................................... 14 
12.1 CODE OF CONDUCT ..................................................................................................................................... 14 
12.2 ETHICS COMMITTEE / INSTITUTIONAL REVIEW BOARD APPROVAL AND OVERSIGHT ................................ 14 
12.3 INFORMED CONSENT AND SUBJECT CONFIDENTIALITY .............................................................................. 15 
APPENDIX A ............................................................................................................................................ 19 
SAMPLE INFORMED CONSENT ........................................................................................................ 19 
APPENDIX B ............................................................................................................................................ 20 
CASE REPORT FORM ........................................................................................................................... 20 
APPENDIX C ............................................................................................................................................ 21 
INSTRUCTIONS FOR USE .................................................................................................................... 21 
APPENDIX D ............................................................................................................................................ 22 
SPONSOR COMMITMENTS ................................................................................................................. 22 
APPENDIX E ............................................................................................................................................ 23 
INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES ................................................. 23 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            5 
 
 
 
 
AZIYO BIOLOGICS, INC. 
 
 
 
 
STUDY COORDINATION 
 
 
 
 
 
STUDY SPONSOR 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 
 
 
 
DATA COORDINATION 
CENTER 
 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 

 
Protocol 14-PR-1110D                                                                                                            6 
 
 
Study Synopsis  
 
OBJECTIVE 
The objective of the SECURE Study is to actively gather additional 
information on the use of the CanGaroo ECM® Envelope in a post 
market observational study. 
STUDY 
POPULATION 
 1000 subjects who have received CanGaroo ECM® Envelope for an 
implantable electronic device placement. 
INDICATIONS FOR 
USE 
 CanGaroo ECM® Envelope is intended to securely hold an implantable 
electronic device to create a stable environment when implanted in the 
body.  The devices that may be used with the CanGaroo ECM® 
Envelope include pacemaker pulse generators, defibrillators, or other 
cardiac implantable electronic device.   
ENDPOINTS 
The endpoints will be defined as: 
1. The proportion of subjects with CanGaroo ECM related adverse 
events. 
2. The incidence of major pocket infection. 
EXAMINATION 
SCHEDULE 
In-office wound check, 4-6 week, 3 month and an additional visit 
occurring at any time point after 3 month visit following an implantable 
electronic device procedure utilizing CanGaroo ECM®. 
CLINICAL 
PARAMETERS 
The following clinical data will be collected at post-operative visits: 
• Informed Consent 
• Demographic information 
• Risk factors for infection 
• Implant procedure  
• Type of device implanted  
• Information on CanGaroo ECM 
• CanGaroo ECM related adverse events 
• Information on infections 
ANALYSIS 
Outcomes for the SECURE Study will be compared to data collected 
from the U.S. Healthcare Cost and Utilization Project family of 
databases and/or contemporary literature. 

 
Protocol 14-PR-1110D                                                                                                            7 
 
1.  Introduction and Rationale 
 
Broader indications for the implant of cardiac implantable electronic devices (CIED), a 
higher prevalence of systolic heart failure and population aging are the main reasons for the 
continuous increase in the use of pacemakers, implantable cardioverter-defibrillators and 
devices for cardiac resynchronization therapy.  The rate of infection is out of proportion to 
the increase in implantation rate.  This is thought to be primarily due to the associated 
comorbities in CIED patients, the greater complexity of the devices, and the increased 
duration of procedures.   
 
The CanGaroo ECM Envelope is a ‘pouch’ in which a cardiac implantable electronic device 
is placed prior to implantation to create a stable environment and to provide a barrier 
between the CIED and the soft tissue of the patient and a barrier from the CIED leads. 
 
CorMatrix Cardiovascular, Inc. received FDA 510(k) premarket clearance for the CanGaroo 
ECM (K140306) on August 15, 2014.  This post market observational study will evaluate the 
safety and effectiveness of  CanGaroo ECM following an implantable electronic device 
procedure utilizing  CanGaroo ECM.  Specific data will be collected at the first post-
operative visit.     
 
2. Indication for Use  
 
The CanGaroo ECM Envelope is intended to securely hold an implantable electronic device 
to create a stable environment when implanted in the body. The devices that may be used 
with the CanGaroo ECM Envelope include pacemaker pulse generators, defibrillators, or 
other cardiac implantable electronic device.  The entire Instructions for Use (IFU) can be 
found in Appendix C. 
 
3. Description  
 
The CanGaroo ECM is constructed from a multilaminate sheet (4-ply) of decellularized, non-
crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal 
submucosa (SIS).  SIS is a natural collagen construct derived from a select layer of tissue that 
is recovered from porcine small intestine.  During processing, the inner and outer muscle 
layers of the intestine are removed, leaving an intact, decellularized, submucosa with a 
portion of the tunica propria layer attached to the inner surface.  The CanGaroo ECM 
Envelope will be provided sterile and is intended for single use in a single patient only.  Over 
time, the device will be reinforced by cellular infiltration and tissue growth that will integrate 
the CanGaroo ECM Envelope. 
 
 

 
Protocol 14-PR-1110D                                                                                                            8 
 
4. Prior Clinical Evaluations 
 
 ECM has been studied in previous prospective clinical evaluation, and a post-market clinical 
study is ongoing.  The ECM for Pericardial closure has been studied in a randomized, 
prospective study to evaluate its ability to reduce the incidence of new onset atrial 
fibrillation; the ECM for Carotid Repair is under evaluation in a post-market study to capture 
and assess device performance data from subjects undergoing patch angioplasty of the 
carotid artery following carotid endarterectomy using the product per its FDA-cleared 
Indications for Use; and a post market study to capture additional information (RECON) 
from subjects undergoing a procedure requiring pericardial closure using the product per its 
FDA-cleared Indications for Use.   
 
4.1.Clinical Evaluation of the ECM Pericardial Closure Device 
 
The ECM Pericardial Closure device was evaluated in a multicenter, prospective, 
randomized, controlled clinical study, to demonstrate the safety and effectiveness of the 
device to reduce the incidence of new onset postoperative atrial fibrillation by 
circumferentially reconstructing the normal pericardial anatomy following isolated, first-
time, coronary artery bypass grafting (CABG) procedures as compared to the control 
group subjects who did not undergo pericardial closure.  Safety was to be established by 
demonstrating that the composite clinical event rate for the ECM group was not worse 
than the control group.  Effectiveness was to be established by demonstrating a reduced 
incidence of new onset post-operative atrial fibrillation in the ECM group as compared to 
the control group.  440 patients at 15 U.S. sites were enrolled between December 2010 
and November 2012 and randomized in a 1:1 ratio into either the ECM group (pericardial 
closure) or the control group (no pericardial closure).  A blinded, independent core 
laboratory evaluated all arrhythmia data to determine if subjects met the effectiveness 
endpoints.  A blinded, independent Clinical Events Committee adjudicated all safety 
endpoint events.  Patients were evaluated at hospital discharge, 30 days and 270 days 
postoperatively.  Subjects were adults (at least 18 years of age) with no prior history of 
atrial fibrillation or history of anti-arrhythmia drug treatment in the past three months and 
no implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and 
without defibrillator capabilities [CRT-Ds and CRTs), implantable cardioverter-
defibrillators [ICDs] and pacemakers) undergoing isolated, first-time CABG with a 
median sternotomy approach. 
 
The primary effectiveness endpoint, superiority of the ECM over no pericardial closure 
for reduction in the incidence of new onset post-operative atrial fibrillation, was not met. 
The study results showed that the rate of new onset post-operative atrial fibrillation for 
the primary effectiveness endpoint was similar between the two groups, with a rate of 
38.3% in the ECM group compared with 35.9% in the control group.  The two secondary 
effectiveness endpoints, the rate of treated or sustained episodes of new onset 
postoperative atrial fibrillation (defined as a single episode that last 15 minutes or more) 
and the rate of treated episodes of new onset postoperative atrial fibrillation showed 
results were also similar between the two groups. 

 
Protocol 14-PR-1110D                                                                                                            9 
 
 
The composite primary safety endpoint event rates for the ECM and control group were 
3.9% and 3.7%, respectively.  Using the protocol specified non-inferiority margin, 7.5%, 
the ECM was shown to be non-inferior to control for the primary safety endpoint 
(p<0.001).  Therefore, the primary safety endpoint for the study was achieved.  The 
composite secondary safety event rate was similar for the two groups (5.8% for the ECM 
group compared with 3.9% for the control group) demonstrating no significant increase 
in the rate of bypass graft failure in the ECM group compared with the control group. 
 
Although the study failed to demonstrate a reduction in the incidence of new onset post-
operative atrial fibrillation, the study demonstrated that the ECM for Pericardial Closure 
continues to be safe for its intended use, with no significant increase in the rate of bypass 
graft failure or cardiac tamponade compared with no pericardial closure. 
 
4.2 Post-market Clinical Evaluation of the ECM for Carotid Repair 
 
Aziyo is currently conducting a post-market registry study for the ECM for Carotid 
Repair (Protocol No. 11-PR-1021).  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 ECM for Carotid Repair per its commercial 
Indications for Use.  This registry provides an ongoing post-market surveillance 
mechanism to document clinical outcomes on the use of the ECM for Carotid Repair.  
This is a multi-center, prospective, single-arm, post-market, observational registry of 
subjects receiving the 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. 
One-hundred and eighty-six patients are enrolled in the study and included in the interim 
analysis of the ECM for Carotid Repair registry.  The data demonstrated that the rate of 
device related adverse events were consistent with the rates found in the review of the 
contemporary literature for patch angioplasty.  Specifically, no unanticipated events were 
found and the rate of the events was as anticipated in the risk management plan.  Of 
specific interest in the analysis was the rate of pseudoaneurysm, which was present in 2 
(1.08%) of the 186 patients and compared favorably to the rates found in the literature 
(1.4% to 5%). 
The mean carotid stenosis (maximum) at pre-operative was 84.8%.  Mean change from 
baseline values were -56.8%, -57.9%, and -59.6% at the 1 to 3-month, 6-month, and 12-
month follow-up evaluations.  The mean carotid stenosis (minimum) at pre-operative was 
71.7%.  Mean change from baseline values were -63.9%, -61.2%, and -63.4% at the 1 to 
3-month, 6-month, and 12-month follow-up evaluations. 
 
As a result of this analysis and the directed and ongoing risk management activities, the 
overall residual risk of the ECM for Carotid Repair is determined to be acceptable. 

 
Protocol 14-PR-1110D                                                                                                            10 
 
5. Study Objectives 
 
The objective of the SECURE Study is to actively gather additional information on the use of 
the CanGaroo ECM® Envelope in a post market observational study. 
 
Endpoints 
The endpoints will be defined as: 
1. The proportion of subjects with CanGaroo ECM related adverse events. 
2. The incidence of major pocket infection. 
 
Major infection will be defined as 1) superficial cellulitis in the region of the CIED pocket 
with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space 
(pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.  Minor CIED 
infections include any that do not meet the definition of a major CIED infection.  
Documentation will also be provided in the medical records.   
 
6.  Study Design 
 
This is a multi-center post-market observational study.  It is anticipated that up to 1000 
subjects will be enrolled at up to 50 centers.  Eligible candidates will be approached to 
ascertain interest in study participation at their initial follow up visit.  If a subject is interested 
in participating and has had CanGaroo ECM used in their procedure, they will be asked to 
allow their physician to use their medical information from the procedure and four follow up 
visits.  An informed consent will be provided to the patient and the patient will be asked to 
sign unless a Waiver of Documentation of Consent has been obtained.  If a Waiver of 
Documentation of Consent is in effect, all elements of the approved informed consent will be 
provided verbally and the process will be documented in the subject study binder by the 
research staff for either method of consent.   
 
7.  Study Population 
 
The study population will consist of any subject who has received the CanGaroo ECM® 
Envelope for an implantable electronic device placement.  Subjects will be considered 
enrolled into the study once they have provided informed consent and completed the 
procedure using the CanGaroo ECM Envelope.  Before any subject can be enrolled, the site 
must have IRB approval from a centralized IRB or their specific institution IRB for the 
protocol and Informed Consent Form to be used at that site and Waiver of Documentation of 
Consent, if applicable.  
 
8.  Study Methods 
 
Study procedures are standardized to the extent possible and all study-related data will be 
captured on a standardized Case Report Form and entered by sponsor personnel into Clindex, 
Version 3.11.0.1027R, an electronic data capture software. A copy of the Case Report Form 
is provided in Appendix B. 

 
Protocol 14-PR-1110D                                                                                                            11 
 
 
9.   Study Procedures 
 
Patients return for an in-office wound check, a 4-6 week, 3 month and any visit 
following the 3 month visit depending on the investigator’s standard of care for 
follow up.  If the subject is unable to return to the clinical site for all visits, the 
site may contact the subject or the referring physician to provide follow-up data to 
study site by telephone. 
  
The following information collected and documented: 
 
• Informed Consent 
• Demographic information 
• Risk factors for infection 
• Implant procedure  
• Type of device implanted 
• Information on CanGaroo ECM 
•  CanGaroo ECM related adverse events 
• Information on infections 
 
 
All study-related data will be captured on a standardized Case Report Form.  A copy of 
the Case Report Forms is provided in Appendix B.  Case report forms will be sent to 
Aziyo via email or fax. 
 
Stephanie Beall 
Aziyo Biologics, Inc. 
1100 Old Ellis Road, 1200 
Roswell, GA  30076 
(470) 514-4031 Direct Office 
(678) 566-2680 Fax 
sbeall@aziyo.com 
10. Adverse Event Reporting 
10.1 Definitions 
 
Adverse Event (AE)  
 
Adverse event (AE) will be defined as any untoward medical occurrence, unintended 
disease or injury or any untoward clinical signs in subjects whether or not related to the 
device.  This includes events related to the device and to the procedure involved.   For 
this post market clinical study only events that relate to the use of the CanGaroo ECM 
will be collected and is defined below in Adverse Device Effect. 
 

 
Protocol 14-PR-1110D                                                                                                            12 
 
Adverse Device Effect (ADE) 
An Adverse Device Effect is defined as a clinical sign, symptom, or condition that is 
causally related to the device procedure, the presence of the device, or the performance of 
the device.  Due to the temporal proximity of the AE to product administration, there is a 
reasonable possibility that the product may have caused the AE or may have contributed 
to the severity or duration of an event caused by other means.   
 
Serious Adverse Event (SAE) 
A serious adverse event is defined as an event that:  a) led to death, b) led to serious 
deterioration in health that either: 
1) Resulted in life threatening illness or injury, or 
2) Resulted in a permanent impairment of a body structure or body function, or 
3) Required in-patient hospitalization or prolongation of existing hospitalization, or 
4) Resulted in medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function. 
 
A planned hospitalization for pre-existing condition without a serious deterioration in 
health, is not considered to be a serious event.   
 
 
10.2 Assessing and Recording Adverse Events 
 
Each AE recorded must be documented on the Case Report Form.  All serious and device 
related events must be reported immediately to Aziyo via telephone or email within 24 
hours of the Investigator becoming aware of the event.  The case report form will be 
submitted to Aziyo.  The site will be contacted by Aziyo for additional information 
including, but not limited to: 
 
• Description of the event and underlying cause (diagnosis), coexisting disease, or 
other.  The AE should be recorded in standard medical terminology rather than 
the subject’s own words when possible. 
• Date of onset and date of resolution.  If the event is present at the single post-
operative visit it will be noted as unresolved.  
• Intensity of the event:  mild, moderate, or severe. 
• Frequency of the event:  single episode, intermittent, or continuous. 
• Action taken:  none, medication, procedure, medication and procedure, or other.   
• Relationship to the device/procedure/surgery:  not-related, possibly-related, or 
probably-related.  
 
The Investigator must ensure that the details of the event are documented in the medical 
notes including full details of the outcome, in addition to recording the event on the case 
report form.   
 
All 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 

 
Protocol 14-PR-1110D                                                                                                            13 
 
Device Report will be reported by the Sponsor to the FDA in accordance with Sponsor’s 
Medical Device Reporting SOP.  The site should contact: 
 
 
Stephanie Beall 
Aziyo Biologics, Inc. 
1100 Old Ellis Road, 1200 
Roswell, GA  30076 
(470) 514-4031 Direct Office 
(678) 566-2680 Fax 
sbeall@aziyo.com 
 
10.3 Possible Adverse Events 
 
This study will capture events reported following the procedure and at follow up visits as 
reported by the PI and/or subject and from a review of medical records. The following 
device-related events have been identified as possible risks from the procedure: 
 
• Allergic reaction to ECM 
• Bleeding 
• Calcification 
• Fever 
• Fibrosis 
• Hematoma 
• Infection 
• Inflammation 
• Seroma 
• Undesired remodeling 
 
There are no identified risks involved in participating in this post-market study. 
11. 
Data Analysis   
The primary endpoints are as follows: 
   1. The proportion of subjects with CanGaroo ECM related adverse events. 
   2. The incidence of major pocket infection. 
 
Point estimates and exact 95% binomial confidence intervals will be provided for the true 
(population) values of these two endpoints.  
 
The number and percentage of subjects with AEs and with device-related AEs will be 
presented by type of AE.  
 

 
Protocol 14-PR-1110D                                                                                                            14 
 
If possible, the rate of major pocket infection will be compared to the rate without use of 
the CanGaroo ECM device based on data from the U.S. Healthcare Cost and Utilization 
Project family of databases and/or contemporary literature. 
 
Similarly, if possible, the rate of other AEs will be compared by type to the rate without 
use of the CanGaroo ECM device based on data from the U.S. Healthcare Cost and 
Utilization Project family of databases and/or contemporary literature. 
 
 
12.  Ethical Considerations 
12.1 Code of Conduct 
 
The Investigator will ensure that the clinical study is conducted in accordance with good 
clinical practice and all regulatory and institutional requirements, including those for 
subject privacy, informed consent, Institutional Review Board or Ethics Committee 
approval, and record retention.  (Appendix D:  Investigator Qualifications and 
Responsibilities) 
 
Data quality will be monitored through review of submitted data to identify and follow up 
on missing data, inconsistent data, or incomplete data.  Critical data points such as 
adverse events or infection will be reviewed with the site via telephone and/or email and 
if required, on-site monitoring will be conducted.  All communication with the 
investigator and study staff related to monitoring and data collection will be documented 
per the Monitoring SOP.  Monitoring and related activities will be performed by the 
Sponsor or its designee. 
    
12.2 Ethics Committee / Institutional Review Board Approval and Oversight 
 
The Investigator must obtain appropriate Ethics Committee (“EC”) or Institutional 
Review Board (“IRB”) approval before the study can be initiated.  The Sponsor will 
submit the protocol and informed consent to a centralized IRB for approval.  If the 
Investigator chooses to use the centralized IRB, the Investigator will be responsible for 
completing the initial review form for the Sponsor to submit on their behalf.  If the 
investigator chooses to us their own IRB, the sponsor will provide support for the 
compilation and submission of the IRB package.  A copy of the written approval from the 
EC/IRB and a copy of the approved Informed Consent Form (approved Waiver of 
Documentation of Consent, if applicable) should be sent to Aziyo.  Appropriate study 
progress reports will be prepared for the EC/IRB by the Principal Investigator. Any 
changes to the protocol must be discussed and approved by Aziyo in writing unless the 
change is made to assure the safety of the subject.  In the non-emergent setting, after 
agreement on the changes has been reached, an amendment to the protocol will be 
provided by Aziyo for submission to the EC/IRB for review and approval prior to 
initiation of the change.  Any change made emergently must be documented in the 

 
Protocol 14-PR-1110D                                                                                                            15 
 
subject's medical record.  The Investigator must immediately forward to the EC/IRB any 
written safety reports or updates from Aziyo.   
12.3 Informed Consent and Subject Confidentiality 
 
The Informed Consent/Waiver of Documentation of Consent and protocol must be 
approved by the local/centralized EC/IRB before the study is initiated and subjects 
enrolled.  Prior to obtaining any study specific information approved informed consent 
will be reviewed with the subject and the subject must provide approval.  Documentation 
of the consent process must be completed by the research personnel.  The investigator 
shall provide a copy of the Informed Consent to the subject.  Completed documentation 
of the consent process will be available for auditing by Aziyo or their representative, as 
applicable.   
  
 
Aziyo will maintain the confidentiality of the identity of subjects enrolled in the study 
and the information contained in their study records.  Aziyo will also instruct the study 
investigators in the importance of maintaining the confidentiality of study records.  Any 
publication of any data collected as part of this trial will only use de-identified data, so 
that identification of any individual subject will not be possible.  The records will be 
made available as required for review by the FDA, or other applicable regulatory agency 
and a reviewing IRB; however to the extent possible, the subject’s identity will not be 
disclosed.  The Case Report Forms will use a subject identification number, with the 
patient name and address NOT appearing anywhere on the study form to be submitted to 
the sponsor (Appendix E:  Sponsor’s Commitments). 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            16 
 
 
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Protocol 14-PR-1110D                                                                                                            17 
 
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Am Coll Cardiol. 2013; 62(3):e5. 
 
Quarti A, Nardone S, Colaneri M, Santoro G, Pozzi M. Valve leaflet reconstruction in 
pediatrics with extracellular matrix patch. J Heart Valve Dis. 2012; 21(1):138-139. 
 
Sundermann SH, Biefer HR, Emmert MY, Falk V. Use of Extracellular Matrix Materials in 
Patients with Endocarditis.Thorac Cardiovasc Surg. 2012;Epub ahead of print. DOI: 
10.1055/s-0032-1328920 
 
Smith CR, Stamou SC, Boeve TJ, Hooker RC. Repair of a penetrating ascending aortic ulcer 
with localized resection and extracellular matrix patch aortoplasty. Ann Thorac Surg. 2012; 
94(3):988-989. 
 
Chalajour F, Barboza LA, Boni L et al. Reconstruction of pulmonary artery in a newborn 
using a porcine small intestinal submucosal patch. Ann Thorac Surg. 2012; 93(4):1311-1315. 
 

 
Protocol 14-PR-1110D                                                                                                            18 
 
Mavroudis CD, Casillan A, Rabbat M et al. Primary Intimal Sarcoma of the Pulmonary Vein 
with Extension into the Left Atrium: A Case Report. Open Journal of Thoracic 
Surgery. 2012; 2(2):25-28. 
 
Tweddell JS, Mitchell ME, Woods RK, Spray TL, Quintessenza JA. Construction of the Right 
Ventricle-to-Pulmonary Artery Conduit in the Norwood: The "Dunk" Technique. Operative 
Techniques in Thoracic and Cardiovascular Surgery. 2012; 17(2):81-98. 
 
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Quarti A, Nardone S, Colaneri M, Santoro G, Pozzi M. Preliminary experience in the use of 
an extracellular matrix to repair congenital heart diseases. Interact Cardiovasc Thorac 
Surg. 2011; 13(6):569-572. 
 
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for aortic annular enlargement during aortic valve replacement. Innovations. 2010; 5(1):60-62. 
 
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cardiac reconstruction using decellularized porcine extracellular matrix scaffold: human 
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Surgery. 2010; 1(1):132-136. 
 
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using an extracellular matrix implant correlates with reduced risk of postoperative atrial 
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J Mol Sci. 2009; 10(10):4375-44

 
Protocol 14-PR-1110D                                                                                                            19 
 
 
Appendix A 
Sample Informed Consent 
 
 
To be provided as a separate document 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            20 
 
Appendix B 
Case Report Form 
 
 
To be provided as a separate document 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            21 
 
Appendix C 
Instructions for Use 
 
 
To be provided as a separate document 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            22 
 
Appendix D 
Sponsor Commitments 
 
 
 
 
SPONSOR’S COMMITMENTS 
Aziyo is committed to: 
1. Complying with the Declaration of Helsinki and all applicable health authority 
regulations governing the conduct of clinical research studies. 
2. Protecting the rights, health, safety and welfare of study subjects. 
3. Informing the clinical investigators of any new information about the study which may 
affect the health, safety, or welfare of the subjects, or may influence their decision to 
continue participation in the study. 
4. Providing the clinical investigators with the study protocol and Case Report Form on 
which to document the study evaluation variables for each subject entered into the study. 
5. Providing the clinical investigators and study staff training on the protocol and 
completion of the Case Report Form. 
6. Providing the statistical analysis and study report writing resources necessary to complete 
reporting of the study results. 
7. Certifying that EC/IRB approval of the protocol and Investigators Agreement will be 
completed prior to study initiation at a clinical site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol 14-PR-1110D                                                                                                            23 
 
Appendix E 
Investigator Qualifications and Responsibilities 
 
INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES 
 
Each investigator must be a licensed physician who has received training for using the CanGaroo 
ECM®. The investigators have the following responsibilities: 
 
1. Subject Selection 
The investigator is responsible for assuring that all subjects entering the study are eligible to 
participate. 
 
2. Informed Consent 
The investigator is responsible for fully reviewing the nature of the study.  The investigator is 
responsible for ensuring that Informed Consent is conducted by a qualified study team 
member in compliance with applicable regulations for each patient, prior to enrollment in the 
trial.  A copy of the Informed Consent Form and documentation of the Informed Consent 
Process will be maintained in the patient's medical record. 
 
3. Ethics Committee (EC)/Institutional Review Board (IRB) Approval 
The investigator must obtain approval for his participation in this protocol from an EC/IRB 
prior to entering any patients in the study.  The Informed Consent document to be used will 
also be submitted by the Investigator or by qualified study team member to the EC/IRB for 
approval prior to initiation of the study.  Assurance that the EC/IRB approval of the study 
protocol and Informed Consent has been obtained will be provided to the Sponsor prior to 
initiation of the study. 
 
4. Subject Evaluation and Data Reporting 
The investigator is responsible for performing the patient evaluations or delegate to a 
qualified study team member, as described in the study protocol.  All information generated 
by the patient evaluation will be recorded on the Case Report Form.  Source documents will 
be maintained at the site. 
 
5. Record Retention 
The Investigator or qualified study team member must retain all subject records for at least 2 
years, or longer, if required by local regulations.