Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Conditions: Carotid Artery Stenosis
Sponsor: Integra LifeSciences Corporation

 
 
COVER PAGE 
 
 
 
 
Protocol Title: Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF) 
Protocol Number: C-SCS-001 
Version / Date: Version 1.0 / 28-Nov-2018 
NCT ID: 03816202 
 
 
 
Sponsor: 
Integra LifeSciences 
Current Address: 
1100 Campus Road, 
Princeton, NJ 08540 
 
Previous Address: 
311 Enterprise Drive 
Plainsboro, NJ 08536  

 
 
 
Sundt™ Carotid Shunt Retrospective Post 
Market Clinical Follow-up Study (PMCF) 
 
 
 
PROTOCOL NO.:  C-SCS-001 
VERSION / DATE:  Version 1.0 / 28-Nov-18 
VERSION HISTORY:  First  
  
SPONSOR:  Integra LifeSciences Corporation 
311 Enterprise Drive 
Plainsboro, NJ  08536, USA 
 
 
 
 
 
 

 Integra LifeSciences  
 
 
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Confidential  
Protocol Version 28-Nov-2018 
Protocol Version Number 1.0 
 
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HISTORY TABLE 
Version Number # 
Brief Summary of Updates 
Date 
Version 1.0 
First 
28-Nov-2018 

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TABLE OF CONTENTS  
HISTORY TABLE ............................................................................................................ 2 
TABLE OF CONTENTS .................................................................................................. 3 
STATEMENT OF COMPLIANCE .................................................................................... 4 
STUDY SYNOPSIS ......................................................................................................... 5 
1 
INTRODUCTION ...................................................................................................... 8 
1.1 
Background......................................................................................................................... 8 
1.2 
Study Device....................................................................................................................... 8 
1.2.1 
Device Description ................................................................................................... 8 
1.3 
Intended Use ...................................................................................................................... 9 
1.4 
Sponsor Contact Information .............................................................................................. 9 
2 
OBJECTIVE AND ENPOINTS .................................................................................. 9 
2.1 
Primary Objective ............................................................................................................... 9 
2.2 
Primary Study Endpoint ...................................................................................................... 9 
3 
STUDY DESIGN ...................................................................................................... 9 
3.1 
Study Duration .................................................................................................................. 10 
3.2 
Study Sample Size ........................................................................................................... 10 
4 
SUBJECT POPULATION ....................................................................................... 10 
4.1 
Inclusion Criteria ............................................................................................................... 10 
4.2 
Exclusion Criteria .............................................................................................................. 10 
5 
STUDY PROCEDURES ......................................................................................... 10 
5.1 
Device Performance ......................................................................................................... 12 
6 
STATISTICAL ANALYSIS ...................................................................................... 13 
7 
ETHICS AND REGUALTORY REQUIREMENTS ................................................... 13 
7.1 
Confidentiality ................................................................................................................... 13 
7.2 
Waiver of Consent ............................................................................................................ 13 
7.3 
Waiver of HIPAA Authorization ......................................................................................... 13 
8 
STUDY FINANCES ................................................................................................ 14 
9 
RETENTION .......................................................................................................... 14 
10 STUDY REGISTRATION AND PUBLICATION PLAN ............................................ 14 
11 REFERENCES....................................................................................................... 15 
 
 

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STATEMENT OF COMPLIANCE 
By signing this document, I, the Investigator, certify that this trial will be carried out in 
accordance with International Conference on Harmonisation Good Clinical Practice (ICH 
GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical 
studies (45 CFR Part 46, 21 CFR Part 50, and 21 CFR Part 56)  
 
Additionally, I and any clinical trial site staff who are responsible for the conduct, 
management, or oversight of this trial will complete Human Subjects Protection/ICH GCP 
Training. 
 
The protocol associated with this trial will be submitted to an Institutional Review Board 
(IRB)/Ethics Committee (EC) for review and approval.  Approval of the protocol must be 
obtained before any participant is enrolled.   
 
Finally, I understand that any amendments to the protocol will require review and approval 
by the IRB before the changes are implemented to the study.   
 
 
 
 
Investigator Name 
 
 
 
Investigator Signature  
Date 

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Sundt™ Carotid Shunt PMCF Study 
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STUDY SYNOPSIS 
PROTOCOL TITLE: Sundt™ Carotid Shunt Post Market Clinical Follow-up (PMCF) 
Study  
STUDY DESIGN: 
Non-randomized, multi-center, single-arm, all-comers, 
retrospective Post Market Clinical Follow-up study 
PRIMARY 
OBJECTIVE: 
The primary objective of this study is to retrospectively investigate 
the safety and efficacy of the Integra Sundt™ carotid shunt during 
endarterectomy procedures. 
PRIMARY 
ENDPOINT: 
The primary endpoint of this study is evidence of injury to the 
artery or cerebral ischemia secondary to shunt placement and 
removal. 
INDICATION: 
The Integra Sundt™ carotid shunts are indicated for temporary 
carotid artery bypass during carotid endarterectomy procedures 
to help protect the cerebral hemispheres from ischemia during the 
period of carotid artery occlusion.   
STUDY 
POPULATION: 
100 subjects, both male and female, between the ages 18 to 80 
in the United States will be recruited for this trial.  
INCLUSION 
CRITERIA: 
Subjects will be included in this study if they meet all of the 
following inclusion criterion: 
1. Between the ages of 18-80 years old 
2. Have undergone carotid endarterectomy with any Integra 
Sundt™ carotid shunt on or before date of study initiation 
3. Availability of records on post-operative imaging of the 
carotid artery either by carotid duplex ultrasound or 
angiogram 
EXCLUSION 
CRITERIA: 
Subjects will not be included in this study if they meet the following 
exclusion criterion: 
1. Insertion of a carotid shunt at the site of an infection 

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DESCRIPTION OF 
SITES: 
A minimum of 3 sites and a maximum of 10 sites will participate 
in this study. A maximum of 40 consecutive patients will be 
enrolled at each site. This study will take place in the United 
States only. 
STUDY 
DURATION: 
The study duration from the first patient’s chart review to the 
completion of the last patient’s chart review is expected to be 1 
year. The study will end when the data for 100 subjects have been 
collected.  
DATA 
COLLECTION: 
Retrospective review of patients who underwent carotid 
endarterectomy will include demographics, procedure details, 
safety events, and a post-operative assessment.  
• 
Demographics 
o Age 
o Gender 
o Height  
o Weight  
o Relevant Past Medical History 
• 
Transient Ischemic Attack (TIA) 
• 
Stroke 
• 
Asymptomatic Carotid Stenosis 
• 
Bleeding Disorder 
• 
Diabetes 
• 
Smoking 
• 
Other relevant past medical history per the 
investigator’s opinion 
o Relevant Past Surgical History 
• 
Previous Head or Neck Surgery 
• 
Previous Head or Neck Radiation 
• 
Previous Vascular Surgery 
• 
Other relevant surgical history per the 
investigator’s opinion 
o Diagnosis / Indication for Surgery 
o Relevant Medications 
• 
Procedure 
o Date of surgery 

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o Procedure(s) performed 
o Duration of surgery 
o Device information, including lot number  
o Relevant Medications 
o Any complications noted in the operative report and in 
the investigator’s opinion determined to be related to 
the device 
• 
Post-operative Assessment (up to 60 days post-
procedure) 
o Evidence of cerebral ischemia as indicated by post-
operative neurological exam 
o Evidence of injury to artery as seen on post-operative 
imaging of the carotid either by carotid duplex 
ultrasound or angiogram 
STATISTICAL 
METHODS & 
ANALYSES: 
The post marketing clinical follow up study is a retrospective chart 
review. All analyses will be descriptive in nature. No formal 
statistical analyses will be conducted.  
 
 
 

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1 
INTRODUCTION 
1.1 Background 
Stroke affects nearly 800,000 individuals in the United States per year and is the fifth leading 
cause of death1. Carotid artery stenosis—the narrowing of the carotid arteries due to 
atherosclerotic plaques—is one of the leading causes of stroke. The annual risk of stroke in 
individuals with asymptomatic carotid stenosis (ACS) is about 1 to 3%, but the risk is around 4 to 
12% for individuals with symptomatic stenosis (SCS) without carotid intervention2. Early treatment 
of carotid stenosis (CEA) has the potential to prevent or delay the occurrence of strokes.   
Carotid endarterectomy (CEA) is a surgical procedure to remove the stenosis together with 
unstable plaque, thereby reducing the risk of stroke3. It has been found to be effective in patients 
with high-grade symptomatic (~70%) or asymptomatic (< 60%) internal carotid artery stenosis 
and has been proven to be superior to medical management alone4. Most perioperative strokes 
are ischemic in nature, some of which may be caused by the temporary interruption of blood flow 
during CEA when the carotid artery is clamped3. A carotid shunt may be used to minimize this 
interruption of blood flow and ensure sufficient cerebral perfusion during carotid cross clamping, 
which may decrease the incidence of perioperative stroke. Carotid shunting can either be used in 
all patients undergoing CEA (routine shunting) or in a proportion of patients who are at a high risk 
of developing cerebral ischemia during carotid clamping (selective shunting). However, there is 
no conclusive evidence of the superiority of one method over the other, and it often depends on 
the surgeon’s preference and familiarity with the method3–5.   
1.2 Study Device 
1.2.1 Device Description 
The Integra Sundt™ internal and external (Loop) Carotid Endarterectomy Shunts are designed to 
provide temporary carotid bypass for cerebral circulation during carotid endarterectomy 
procedures.  
The Sundt™ internal and external Carotid Endarterectomy shunts are constructed of silicone 
elastomer with stainless steel spring reinforcement to minimize kinking and occlusion of the 
cannula lumen and to aid in the ease of insertion of the proximal and distal ends. The ends of the 
shunts have cone-shaped bulbs to facilitate fixation of the shunt in the vessel. Quite frequently in 
the internal type shunt a distal tourniquet is not required because, if the proper shunt size is 
selected, the bulb fits firmly enough against the wall of the vessel that there is no bleeding around 
the distal bulb. A tourniquet is always required on the proximal end of both the external and 
internal shunts and usually on the distal end of the external shunt 

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1.3 Intended Use 
The carotid endarterectomy shunts are indicated for temporary carotid artery bypass during 
carotid endarterectomy procedures in order to help protect the cerebral hemispheres from 
ischemia during the period of carotid artery occlusion. These shunts are designed as temporary 
indwelling catheters and are not intended for permanent placement. 
1.4 Sponsor Contact Information 
Samira Lavingia 
Integra LifeSciences Corporation 
311 Enterprise Drive  
Plainsboro, NJ  08536, USA 
609-936-4682 
Samira.Lavingia@integralife.com  
2 OBJECTIVE AND ENPOINTS 
2.1 Primary Objective 
The primary objective of this study to retrospectively investigate the safety and efficacy of the 
Integra Sundt™ carotid shunt during endarterectomy procedures. 
2.2 Primary Study Endpoint  
The primary endpoint of this study is evidence of injury to the artery or cerebral ischemia 
secondary to shunt placement and removal. 
3 STUDY DESIGN 
This is a non-randomized, multi-center, single-arm, all-comers retrospective Post Market Clinical 
Follow-up study investigating subjects who received a Sundt™ carotid shunt during a carotid 
endarterectomy before study initiation at the site.  

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3.1 Study Duration 
The study duration from the first patient’s chart review to the completion of the last patient’s chart 
review is expected to be 1 year. The study will end when the data for 100 subjects has been 
collected.  
3.2 Study Sample Size 
100 patients will be enrolled at up to 10 centers, with up to a maximum of 40 consecutive patients 
enrolled at each center. Patients will be enrolled at a minimum of 3 centers. This study will take 
place in the United States only. 
4 SUBJECT POPULATION 
4.1 Inclusion Criteria 
Subjects will be included in this study if they meet all of the following inclusion criteria: 
1. Between the ages of 18-80 years old 
2. Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt before 
the date of study initiation  
3. Availability of records on post-operative imaging of the carotid artery either by carotid 
duplex ultrasound or angiogram 
4.2 Exclusion Criteria  
Subjects will not be included in this study if they meet the following exclusion criterion: 
1. Insertion of a carotid shunt at the site of an infection 
5 STUDY PROCEDURES 
This study is a retrospective review of patients who have undergone a carotid endarterectomy 
procedure with the use of the Sundt™ carotid shunt prior to study initiation.  
Eligible subjects for the study should be identified by the 3-digit site number followed by the 3-
digit subject ID. Numbering of the subjects should be done in a reverse chronological order with 
the most recent subject being 001 followed by the second most recent being 002 and so forth.  
Required information will be collected through a review of the patient chart or electronic medical 
records (EMR) by the Principal Investigator or delegated personnel. The delegated staff 

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member shall collect demographics, details surrounding the procedure, and the post-operative 
assessment.  
• 
Demographics 
o Age 
o Gender 
o Height 
o Weight 
o Relevant Past Medical History 
• 
Transient Ischemic Attack (TIA) 
• 
Stroke 
• 
Asymptomatic Carotid Stenosis 
• 
Bleeding Disorder 
• 
Diabetes 
• 
Smoking 
• 
Other relevant past medical history per the investigator’s opinion 
o Past Surgical History 
• 
Previous Head or Neck Surgery 
• 
Previous Head or Neck Radiation 
• 
Previous Vascular Surgery 
• 
Other relevant surgical history per the investigator’s opinion 
o Diagnosis / Indication for Surgery 
o Medications 
• 
Procedure 
o Date of surgery 
o Procedure(s) performed 
o Duration of surgery 
o Device information, including lot number  
o Medications 
o Any complications noted in the operative report and in the investigator’s opinion 
determined to be related to the device 
• 
Post-operative Assessment (up to 60 days post-procedure) 
o Evidence of cerebral ischemia as indicated by post-operative neurological exam 
o Evidence of injury to artery as seen on post-operative imaging of the carotid artery 
either by carotid duplex ultrasound or angiogram 

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5.1 Device Performance  
The delegated site staff will collect information regarding the device performance.  
 
The following device performance questions will be part of the case report form and will be 
collected from the patient medical record including both the operative note and the anesthesia 
record for the procedure.  For the “yes / no” questions below, if the medical record is silent on the 
answer to the question it will be assumed that the answer is “no”. 
1. Was the shunt use routine or selective?  If selective, specify the test and the result that 
led to use of the shunt. 
 
2. Was there any delay in surgery or complication due to preparation of the device for 
surgery? If yes, please explain. 
 
3. What was the clamping method type for shunt insertion?  
 
4. How long was the carotid artery cross clamped for shunt insertion? 
 
5. Was there any device-related damage to the artery during insertion of the shunt? If yes, 
please explain. 
 
6. Was there evidence of clot formation within the shunt at any point during the 
procedure?  If yes, describe how this was detected and what was the remedy.  What 
was the impact to the procedure? 
 
7. Was there any evidence of reduced flow within the shunt other than clot formation (e.g. 
due to kinking, malposition within the artery)? 
 
8. Was there any evidence of excessive bleeding around the shunt after initial placement?  
If yes, what was the remedy and the result of that remedy? 
 
9. Did removal of the shunt cause vessel injury or complicate closure? If yes, please 
explain.  
 
10. Was there evidence of post-operative cerebral ischemia noted in the neurological exam?  
 
11. Did the subject experience injury to the artery due to the device as evidenced by the 
imaging of the carotid artery either by carotid duplex ultrasound or angiogram? 
 
12. Were there any other device-related complications not previously recorded in the case 
report forms? If yes, please explain.  

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6 STATISTICAL ANALYSIS 
The PMCF is a retrospective chart review. All analyses will be descriptive in nature. No formal 
statistical analyses will be performed. The study objectives will be presented by summary 
statistics.   
Summary statistics (mean, standard deviation, quintiles, counts, and percentages) will be 
presented for all demographic (i.e. age, gender, etc.), clinical baseline characteristics (diagnosis, 
medical history, medications), surgical procedures (procedures performed, duration of surgery) 
and complications.   
The primary objective will be evaluated by summarizing the incidence of injury to the artery or 
cerebral ischemia secondary to shunt placement. 
All statistical analysis will be conducted using SAS. 
7 ETHICS AND REGUALTORY REQUIREMENTS 
7.1 Confidentiality 
In order to observe the confidentiality of personal data, each patient will be allocated a confidential 
identification code consisting of the investigator site number followed by a 3-digit patient number. 
CRFs or any other documents submitted to the sponsor will identify the patient by this 
identification code. Each investigator will maintain a patient identification list which would detail 
the identification code along with the corresponding patient identifiers (name and date of birth).  
Each subject should be numbered in reverse chronological order from 001 as the most recent 
subject prior to study initiation at the site. 
7.2 Waiver of Consent 
A waiver of informed consent is key to perform this retrospective chart review study. Informed 
consent will not be possible to obtain as the care has already been provided by the 
surgeon/investigator and it is unlikely the patient will return to the surgeon for a clinical visit. In 
addition, this chart review involves no more than minimal risk to the subjects and the waiver will 
not affect the rights and welfare of the subjects since care has already been given.  
7.3 Waiver of HIPAA Authorization 
Waiver of HIPAA authorization is key for the success of this chart review. Not only will it be difficult 
to obtain the authorization since the care has already been provided by the surgeon/investigator 
and it is unlikely that the patient will return to the surgeon for a clinical visit, but the use or 

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disclosure of protected health information involves no more than a minimal risk to the privacy of 
the individuals.  
8 STUDY FINANCES 
The study will be funded by Integra Lifesciences Corporation. The Sundt™ internal and external 
(Loop) Carotid Endarterectomy Shunt is considered a pre-amendment device and is FDA 
registered under the device listing D024713. 
9 RETENTION 
Study records must be retained by the Investigator for 2 years following the conclusion/ 
termination of the study and the publication (if applicable). Study records should not be destroyed 
without prior written agreement between the Sponsor and the study Investigator. At the 
completion of the study, details of the archival process must be provided to the Sponsor. Study 
records are subject to inspection by applicable health and regulatory agencies at any time.  
10 PUBLICATION PLAN 
A report will be prepared under the responsibility and according to the Integra LifeSciences 
Corporation SOPs. It will include the study objectives, the methodology, statistical analysis and 
raw data listings, and the conclusions of the study.  
The sponsor is not allowed to use investigator's name in any publication without prior written 
consent. The investigator is not allowed to use sponsor's name in any publication without prior 
written consent. 
 
 

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11 REFERENCES 
1.  
Sardar P, Chatterjee S, Aronow HD, et al. Carotid Artery Stenting Versus Endarterectomy for Stroke 
Prevention: A Meta-Analysis of Clinical Trials. J Am Coll Cardiol. 2017;69(18):2266-2275. 
doi:10.1016/j.jacc.2017.02.053 
2.  
Heo SH, Bushnell CD. Factors Influencing Decision Making for Carotid Endarterectomy versus 
Stenting in the Very Elderly. Front Neurol. 2017;8(May). doi:10.3389/fneur.2017.00220 
3.  
Chongruksut W, Vaniyapong T, Rerkasem K. Routine or selective carotid artery shunting for carotid 
endarterectomy (and different methods of monitoring in selective shunting). Cochrane Database 
Syst Rev. 2014;2014(6). doi:10.1002/14651858.CD000190.pub3 
4.  
Kret MR, Young B, Moneta GL, et al. Results of routine shunting and patch closure during carotid 
endarterectomy. Am J Surg. 2012;203(5):613-617. doi:10.1016/j.amjsurg.2011.12.005 
5.  
KATANO H, YAMADA K. Comparison of Internal Shunts during Carotid Endarterectomy under 
Routine Shunting Policy. Neurol Med Chir (Tokyo). 2014;54(10):806-811. doi:10.2176/nmc.oa2013-
0218