Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
Phase: NA
Conditions: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Sponsor: Cook Group Incorporated

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 1 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
 
CLINICAL INVESTIGATION 
TO EVALUATE  
REMOVAL OF THE  
EVOLUTION® ESOPHAGEAL STENT – FULLY COVERED 
(CLARITY) 
 
 
 
Global Clinical Number 11-012 
 
 
Sponsor: 
 
MED Institute, Inc. 
1 Geddes Way 
West Lafayette, IN 47906 
USA 
 
 
Summary of Revisions 
Version # 
Description 
Date 
11-012-01 
Original version 
11 Sept 2012 
11-012-02 
Modifications including inclusion of benign performance goal 
and revision of sample size 
29 Nov 2012 
11-012-03 
Modifications including revision of follow-up windows 
05 Mar 2013 
11-012-04 
Modifications including minor clarifications to 
inclusion/exclusion criteria and migration endpoint 
11 Nov 2013 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 2 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
 
This clinical investigation will be conducted in accordance with the clinical investigation plan 
(CIP), GCP, 21CFR812, and other applicable requirements as appropriate.  The CIP will be 
revised, as appropriate, based on new information. 
 
 
Signatures: 
 
Global Sponsor Contact: 
 
 
X 
  
 
Signature 
 DD MONTH YYYY 
 
Jennifer Kerr, MS, CCRA, RAC 
 Vice President, Global Clinical Affairs  
Printed Name 
 Title 
 
 
 
 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 3 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE, CON’T 
 
Coordinating Clinical Investigator: 
 
I hereby confirm that I approve of this Clinical Investigation Plan (CIP) and agree to comply 
with its terms as laid out in this document. 
 
 
X 
 
 
 
Signature 
 
DD MONTH YYYY 
 
John Vargo, M.D., M.P.H 
 
 
 
Printed Name 
 
Title 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 4 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
CLINICAL INVESTIGATION PLAN SIGNATURE PAGE, CON’T 
 
Principal Clinical Investigator 
I hereby confirm that I approve of this Clinical Investigation Plan and agree to comply with its 
terms as laid out in this document. 
 
 
X 
 
 
 
Signature 
 
DD MONTH YYYY 
 
 
 
 
 
Printed Name 
 
Title 
 
 
 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 5 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
 
CONFIDENTIALITY STATEMENT 
 
 
 
 
 
 
This document shall be treated as a confidential document for the 
sole information and use of the clinical investigation team and the 
IRB. 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 6 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
Table of Contents 
1  Clinical Investigation Plan Overview ................................................................................................ 8 
2  Objectives of the Clinical Investigation ............................................................................................ 9 
2.1 
Primary Objective ............................................................................................................... 9 
2.2 
Additional Objectives ......................................................................................................... 9 
3  Product Description and Intended Use .............................................................................................. 9 
3.1 
General Product Description ............................................................................................... 9 
3.2 
Intended Use ..................................................................................................................... 11 
3.3 
Product Identification and Tracking ................................................................................. 11 
3.4 
Instructions for Use ........................................................................................................... 11 
4  Risk Analysis and Risk Assessment ................................................................................................ 12 
4.1 
Risks and Foreseeable Adverse Events ............................................................................ 12 
4.2 
Methods to Minimize Risks .............................................................................................. 13 
5  Design of the Clinical Investigation ................................................................................................ 14 
5.1 
Type of Investigation ........................................................................................................ 14 
5.2 
Inclusion Criteria .............................................................................................................. 14 
5.3 
General Exclusion Criteria ............................................................................................... 15 
5.4 
Endoscopically-confirmed Exclusion Criteria .................................................................. 16 
5.5 
Endpoints .......................................................................................................................... 16 
5.5.1 
Primary Endpoint .......................................................................................................... 16 
5.5.2 
Secondary Endpoints .................................................................................................... 17 
5.6 
Variables to be Measured to Demonstrate Achievement of Endpoints ............................ 18 
5.7 
Measures to be Taken to Avoid or Minimize Bias ........................................................... 18 
6  Statistical Considerations ................................................................................................................ 18 
6.1 
Hypotheses to be Tested ................................................................................................... 18 
6.1.1 
Hypothesis to be Tested in Patients with Attempted Endoscopic Stent Retrieval ....... 18 
6.1.2 
Hypothesis to be Tested in Patients with Benign Indications....................................... 19 
6.2 
Sample Size ...................................................................................................................... 19 
6.3 
Missing Data ..................................................................................................................... 20 
6.4 
Site-level Poolability ........................................................................................................ 20 
6.5 
General Analysis ............................................................................................................... 21 
6.6 
Limitations of the Investigation ........................................................................................ 22 
7  Methods ........................................................................................................................................... 22 
7.1 
Subject Consent ................................................................................................................ 22 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 7 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
7.2 
Medications....................................................................................................................... 22 
7.3 
Stent Placement Procedure ............................................................................................... 22 
7.4 
Point of Enrollment ........................................................................................................... 23 
7.5 
Post-stent Placement Procedure and Discharge ................................................................ 23 
7.6 
Follow-up Post-stent Placement ....................................................................................... 24 
7.7 
Stent Repositioning ........................................................................................................... 26 
7.8 
Stent Removal ................................................................................................................... 26 
7.9 
Duration of Study and Subject Participation .................................................................... 27 
7.10 
Study Exit ......................................................................................................................... 27 
7.11 
Criteria and Procedures for Withdrawal ........................................................................... 28 
8  Deviations from Clinical Investigation Plan ................................................................................... 28 
9  Data Collection and Reporting ........................................................................................................ 28 
9.1 
Electronic Case Report Forms (eCRF system) ................................................................. 28 
9.2 
Data Reporting .................................................................................................................. 29 
10  Data Management and Quality Assurance .................................................................................... 29 
10.1 
Data Entry and Quality Assurance ................................................................................... 29 
10.2 
Data Monitoring Arrangements ........................................................................................ 29 
11  Safety Monitoring and Procedures for Reporting Adverse Events ............................................... 29 
11.1 
Safety Monitoring ............................................................................................................. 29 
11.2 
Adverse Event Reporting .................................................................................................. 30 
12  Early Termination or Suspension of the Investigation .................................................................. 30 
13  Ethical Considerations ................................................................................................................... 30 
14  Publication Policy .......................................................................................................................... 30 
15  Trial Administration and Investigators .......................................................................................... 30 
15.1 
Approvals and Agreements ............................................................................................... 31 
15.2 
Investigators ...................................................................................................................... 31 
15.3 
Insurance ........................................................................................................................... 31 
16  References ..................................................................................................................................... 31 
 
 
Appendices 
Contact Information........................................................................................................ Appendix A 
Written Procedures for Monitoring Clinical Investigations ........................................... Appendix B 
Definitions ...................................................................................................................... Appendix C 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 8 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
1  Clinical Investigation Plan Overview 
This prospective, multicenter, single-arm clinical investigation will evaluate the endoscopic 
removability of the Evolution® Esophageal fully covered stent.  Patients may be enrolled in the 
study when a patient requires stenting for an obstruction caused by an intrinsic or extrinsic 
malignancy; refractory benign esophageal stricture; or to seal an esophageal fistula, perforation, 
or leak.  Patients will be enrolled at up to 15 investigative sites until a maximum of 130 patients 
have been enrolled to ensure that 58 patients have had endoscopic stent removal attempted after 
an indwell time of at least 7 days, but no more than 6 months.  At least 110 patients with a 
benign stricture, fistula, perforation, or leak will be enrolled to support the effectiveness of the 
stent in benign indications.  Figure 1 presents a flow diagram of the study design. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Study flow diagram. 
Not removed 
within 6 months 
< 7 days 
Informed consent is obtained 
Stent 
removal time
Follow 30 days for AEs, 
then exit study 
Study Exit 
Patient eligible for enrollment (i.e., meets 
inclusion/general exclusion criteria) 
Standard of care endoscopy performed to confirm patient meets at 
least one of the inclusion criteria and none of the exclusion criteria 
(including the endoscopically-confirmed exclusion criteria) 
Stent is placed – patient is enrolled in the study 
Do NOT include in removal 
hypothesis testing 
< 7 days or not 
removed within 
6 months 
> 7 days and  
< 6 months 
Follow 30 days for AEs, 
then exit study 
Include in removal 
hypothesis testing 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 9 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
2  Objectives of the Clinical Investigation 
2.1 
Primary Objective 
The primary objective of this study is to evaluate the endoscopic removability of the stent 
component of the Evolution® Esophageal Stent System – Fully Covered (known as the 
Evolution® Esophageal fully covered stent) when used to treat patients with an obstruction 
caused by an intrinsic or extrinsic malignancy; refractory benign esophageal strictures; or 
esophageal fistulas, perforations, or leaks. 
 
The primary endpoint will be the proportion of patients, of those patients in whom endoscopic 
retrieval is attempted after an indwell time of between 7 days and 6 months, who have successful 
stent removal (see Appendix C) of the Evolution® Esophageal fully covered stent.  Comparing 
the results of this primary endpoint (i.e., successful removal rate) to a performance goal based on 
literature will be the basis for the statistical analysis of the success of the study. 
2.2 
Additional Objectives 
Other objectives for the study are to collect and evaluate additional outcome measures, including 
effectiveness of the stent in benign conditions, as outlined in section 5.5 Endpoints.    
3  Product Description and Intended Use 
3.1 
General Product Description 
The Evolution® Esophageal fully covered stent is a flexible, self-expanding stent constructed of a 
single, woven, nitinol wire (Figure 2).  Due to its design, the stent foreshortens as it expands.  It 
is fully covered. (both internally and externally) with a silicone membrane, with the exception of 
holes made in the apex of the cells at the proximal and distal ends through which the lasso loop 
passes.  To aid in visibility under fluoroscopy, there are four radiopaque marker bands at either 
end of the stent.  The stent has lassos, which include grasping features, at the proximal and distal 
ends of the stent that are used in stent repositioning and stent removal.  The total length of the 
stent is indicated by radiopaque markers on the inner catheter of the delivery system; the 
radiopaque markers indicate the actual stent length when expanded to nominal stent diameter. 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 10 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
 
 
 
 
 
 
 
 
Figure 2. Photograph of the Evolution® Esophageal fully covered stent.  1= Lasso loop grasping feature, 
2 = Crown, and 3 = Radiopaque marker band 
 
The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide, and is 
constrained by an outer catheter.  A pistol-grip delivery handle allows stent deployment or 
recapture (Figure 3). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3. Delivery system handle 
 
 
1 
2 
3 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 11 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
 
 
 
 
 
 
 
 
 
 
 
3.2 
Intended Use 
The Cook Evolution® Esophageal Stent System – Fully Covered is indicated in this study to 
maintain luminal patency of the esophagus in cases of obstruction caused by intrinsic or extrinsic 
malignancies; refractory benign strictures; or to seal esophageal fistulas, leaks, and perforations. 
3.3 
Product Identification and Tracking 
The Evolution® Esophageal Stent System – Fully Covered will be tracked throughout the course 
of the study by means of a Product Log that includes information such as serial numbers, 
quantity, and disposition of product.  A Product Log will be maintained by each investigative 
site.  In addition, information such as the size and lot number of products used in each patient 
will be recorded on individual case report forms. 
 
The device is available in several diameters and length options as detailed in Table 1. 
 
Table 1. Evolution® Esophageal fully covered stent dimensions 
RPN 
Body 
(mm) 
Flange 
(mm) 
Length 
(cm) 
EVO-FC-R-18-23-8-E-CI 
18 
23 
8 
EVO-FC-R-18-23-10-E-CI 
18 
23 
10 
EVO-FC-R-18-23-12-E-CI 
18 
23 
12 
EVO-FC-R-20-25-8-E-CI 
20 
25 
8 
EVO-FC-R-20-25-10-E-CI 
20 
25 
10 
EVO-FC-R-20-25-12-E-CI 
20 
25 
12 
 
3.4 
Instructions for Use 
Refer to the manufacturer’s Instructions for Use (IFU) for the following: 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 12 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
• Complete instructions including storage and handling requirements, preparation for use, 
pre-use checks, and precautions to be taken during use, after use and disposal  
• Complete summary of the necessary training and experience required for use of these 
devices 
• Complete description of the procedures involved in the use of these devices 
• Contraindications, relative contraindications, and warnings for the devices 
 
Please note that the Evolution® Esophageal fully covered stent should be at least 4 cm longer 
than the lesion, allowing for approximately 2 cm beyond the margin of the lesion at both ends. 
The diameter of the stent should be selected according to the relevant anatomical conditions to 
ensure good wall apposition. 
4  Risk Analysis and Risk Assessment 
4.1 
Risks and Foreseeable Adverse Events 
As part of the stent implantation and removal, endoscopic procedures may also need to be 
performed.  These procedures are generally recognized as safe, although risks have been noted 
with these procedures.  Potential risks associated with endoscopic procedures and/or esophageal 
stenting and removal include, but are not limited to: 
• Perforation  
• Hemorrhage  
• Aspiration, reflux, vomiting  
• Fever, infection 
• Allergic reaction (e.g., to medication)  
• Hypotension  
• Respiratory compromise, depression, or arrest 
• Cardiac arrhythmia or arrest 
• Stent misplacement and/or migration 
• Tumor and tissue ingrowth and overgrowth, which may lead to an inability to completely 
remove the stent 
• Dysphagia (e.g., due to partial or complete occlusion) 
• Esophageal ulceration and erosion 
• Tear/tissue damage (including necrosis) 
• Wire entrapment 
• Nausea 
• Pain 
• Foreign body sensation or reaction 
• Esophagitis 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 13 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
• Edema 
• Food bolus impaction 
• Gas bloat syndrome 
• Sensitivity to device components  
• Fistula (e.g., involving trachea, bronchi, or pleural space) 
• Intestinal obstruction secondary to migration 
• Mediastinitis or peritonitis 
• Airway compression 
• Tracheal obstruction 
• Compression of adjacent structures 
• Death (other than due to normal disease progression) 
 
Of these potential risks, the following may be most commonly associated with esophageal stent 
removal: 
• Perforation  
• Hemorrhage 
• Fever, infection 
• Hypotension 
• Cardiac arrhythmia or arrest 
• Esophageal ulceration and erosion 
• Tear/ tissue damage 
• Pain 
• Esophagitis 
• Edema 
• Fistula 
• Mediastinitis or peritonitis 
 
It is also important to note that the decision to remove or reposition the stent is based on the 
physician’s clinical judgment.  Pre-existing conditions (e.g., stricture, fistula, perforation, leak) 
may not be healed at the time of stent removal and may require additional intervention. 
 
4.2 
Methods to Minimize Risks 
This device will be used only by trained gastroenterologists who are experienced in endoscopic 
procedures.  Physicians who may remove the stent endoscopically will be trained on the removal 
procedure. Patients will be selected according to this study’s labeled indication and in 
accordance with the inclusion/exclusion criteria outlined in this document.  There are no 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 14 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
restrictions on the use of medications or other standard of care procedures used to maintain 
patient comfort and speed recovery peri-procedurally. 
 
The device design, non-clinical testing, clinical study design, and manufacturer’s IFU are 
intended to minimize the risks associated with the use of this device.  The risks of the study have 
been minimized and the potential benefits outweigh the risks in light of the importance of the 
knowledge to be gained about the removability of the device. 
5  Design of the Clinical Investigation 
5.1 
Type of Investigation  
This prospective, multicenter, single-arm clinical investigation will evaluate the endoscopic 
removability of the Evolution® Esophageal fully covered stent in patients with esophageal 
obstruction caused by intrinsic or extrinsic malignancies; refractory benign esophageal strictures; 
or esophageal fistulas, perforations, or leaks.  Cook believes a single-arm clinical study will 
provide the best valid scientific evidence of the ability to safely remove the stent.  
 
Patients will be enrolled at up to 15 investigative sites until a maximum of 130 patients have 
been enrolled to ensure that 58 patients have had endoscopic stent removal attempted after an 
indwell time of at least 7 days, but no more than 6 months.  A patient can be enrolled in the study 
when the patient requires stenting for an obstruction caused by an intrinsic or extrinsic 
malignancy; refractory benign esophageal stricture; or to seal an esophageal fistula, perforation, 
or leak.  Of the 130 patients, it is expected that at least 110 patients with a benign stricture, 
fistula, perforation, or leak will be enrolled to support the effectiveness of the stent in benign 
indications.  If at least 110 patients with benign stricture, fistula, perforation, or leak are not 
enrolled within the first 130 patients, additional enrollment will be requested.  Enrollment is 
expected to be completed within 24 months of initiating the study. 
 
Figure 1 (page 8) presents a flow diagram of the study design. 
 
5.2 
Inclusion Criteria 
Patient enrollment shall be based on known information at the time of procedure.  It will not be 
considered a violation of the clinical investigation plan (CIP) if information obtained at a later 
date contradicts information collected at the time of procedure. 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 15 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
Patient may be included if one of the following is met: 
• 
Diagnosed with a benign esophageal stricture with a history of at least 3 dilations and 
with the expectation of endoscopic stent removal or stent replacement approximately 
6-12 weeks after stent placement 
• Diagnosed with a malignant intrinsic or extrinsic esophageal obstruction (e.g., stricture) 
with the expectation of endoscopic stent removal or stent replacement within 6 months 
after stent placement 
• Diagnosed with a benign esophageal fistula, perforation, or leak with the expectation of 
endoscopic stent removal or stent replacement approximately 6-12 weeks after stent 
placement 
• Diagnosed with a malignant esophageal fistula, perforation, or leak with the expectation 
of endoscopic stent removal or stent replacement within 6 months after stent placement 
 
Note: Physicians will use their best estimate regarding expected time frames for endoscopic stent 
removal or stent replacement when considering a patient for inclusion in the study.  Recognizing 
that several factors may affect the decision of if/when the stent will be removed or replaced, stent 
removal/replacement not performed or performed outside of the expected time frames will not be 
considered a deviation from the clinical investigation plan. 
5.3 
General Exclusion Criteria 
Patient will be excluded if any of the following are met: 
• Patient is < 18 years of age 
• Patient is unable or unwilling to provide written informed consent 
• Patient is unable or unwilling to comply with the follow-up schedule 
• Patient is pregnant, lactating, or planning on being pregnant within the next 6 months 
• Patient is simultaneously participating in another investigational drug or device study, or 
the patient has completed the follow-up phase for the primary endpoint of any previous 
study less than 30 days prior to enrollment in this study 
Note: Patients receiving adjuvant or neoadjuvant therapy for malignancies may 
participate in this study.  This includes treatment protocols with drugs or 
treatments cleared/approved for use in the country where the study is being 
conducted. The patient will not be permitted to enroll if also participating in a 
clinical study of an investigational drug, device, or treatment (e.g., clinical study 
of a drug, device, or treatment not already cleared for use in the country where the 
study is being conducted).  If participating in a clinical study of an investigational 
drug, device, or treatment, patient must be at least 30 days past their primary 
endpoint prior to enrollment in this study. 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 16 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
• Patient has any planned, significant, extra-esophageal surgical or interventional 
procedure within 30 days prior to or following the study procedure 
Note: Any procedure that is directly related to the indication for stenting should 
not be considered a reason for exclusion.  
• Patient that is contraindicated to upper GI endoscopy and/or any procedure to be 
performed in conjunction with esophageal stent placement (e.g., patients in whom 
endoscopy procedures cannot safely be performed) 
• Patient has a medical condition or disorder that would limit life expectancy to less than 
the primary study endpoint or that may cause noncompliance with the protocol or 
confound the data analysis 
• Patient has a known hypersensitivity or contraindication to study products that, in the 
opinion of the investigator, cannot be adequately pre-medicated; study products include 
nitinol (i.e., nickel, titanium) and silicone 
• Patient is not a candidate for tumor reduction therapy or surgical resection 
Note: This criterion applies only to patients diagnosed with a malignant intrinsic 
or extrinsic esophageal obstruction, or with a malignant esophageal fistula, 
perforation, or leak. 
5.4 
Endoscopically-confirmed Exclusion Criteria 
Patient will be excluded if any of the following are met: 
• Strictures that cannot be adequately dilated, if necessary, to allow passage of the delivery 
system  
• Stricture, fistula, perforation, or leak location that requires stent placement within 2 cm of 
cricopharynx 
• Stricture, fistula, perforation, or leak location that requires stent placement in an actively 
bleeding tumor  
• For placement of the stent, patient’s stricture is longer than 8 cm (i.e., requires > 1 stent 
to fully cover with required oversizing) 
5.5 
Endpoints 
5.5.1 Primary Endpoint 
Since the objective of the study is to evaluate endoscopic removability of the stent when used as 
intended, the primary endpoint will be the proportion of patients, in whom retrieval is 
attempted endoscopically after an indwell time between 7 days and 6 months, who have 
successful removal (see Appendix C) of the Evolution® Esophageal fully covered stent.  
Comparing the results of this primary endpoint (i.e., successful removal rate) to a performance 
goal based on literature will be the basis for the statistical analysis of the success of the study.   

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 17 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
Of note, patients with successful study stent removal who require replacement with another non-
study stent will be considered a success within the study. 
5.5.2 Secondary Endpoints 
Secondary endpoints will include: 
• 
Technical success: a stent successfully delivered and placed at its intended location at the 
end of the procedure (note: adjustments made during the procedure are not considered a 
technical failure) 
• 
Clinical success  
o In patients with strictures: improvement or relief of dysphagia symptoms (Appendix C) 
at the 7-day post-stent follow-up 
o In patients with fistulas, perforations, or leaks: seal sufficient to enable oral intake at the 
7-day post-stent follow-up 
Note: Clinical success will be evaluated specifically in benign patients to assess 
effectiveness of the stent in benign indications. 
• 
Dysphagia requiring intervention 
• 
Incidence of procedural- and/or device-related adverse events 
• 
Incidence of stent removal-related adverse events within 30 days following stent removal 
(note: perforations, tears, or fistulas present prior to stent placement will not be considered a 
stent removal-related adverse event if still present upon stent removal) 
• 
Device integrity during the stent removal procedure 
• 
Rate of successful stent removal versus indwell time 
• 
Comparison of successful stent removal following implantation for benign indications 
compared to malignant indications 
• 
Incidence of stent migration over time (assessed, if clinically indicated, through visual 
assessment and/or imaging) 
o Note: Migration in patients receiving tumor reduction therapy (e.g., chemotherapy, 
radiation) may be analyzed separately from migration in the absence of treatment.  
Migration in patients receiving supplemental fixation at the initial implant procedure 
may be analyzed separately from migration in the absence of supplemental fixation. 
 
These endpoints were chosen to supplement the primary endpoint. and were considered the most 
relevant to comprehensively support the safety and effectiveness of this device.  Secondary 
endpoints and additional data fields below will be analyzed for all patients, if applicable, 
including those without stent removal or stent removal at less than 7 days. 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 18 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
5.6 
Variables to be Measured to Demonstrate Achievement of Endpoints 
The primary endpoint will evaluate endoscopic removability of the Evolution® Esophageal fully 
covered stent.  Specifically, the ability to completely remove the stent, incidence of tissue 
damage requiring immediate intervention, and hemorrhage requiring immediate intervention will 
be collected.  Information regarding adverse events will be collected throughout this study during 
clinical assessments or telephone contact with the patients. 
 
Variables to assess secondary endpoints include the ability to deliver and place the stent, 
dysphagia score (including dysphagia requiring intervention), incidence of procedural- and/or 
device-related adverse events, and incidence of stent removal-related adverse events. 
The clinical data will be collected on standardized case report forms.  The schedule for 
assessments is summarized in Table 2 (section 7.6). 
5.7 
Measures to be Taken to Avoid or Minimize Bias 
This study is not randomized or blinded.  It is intended to prospectively collect information 
regarding the endoscopic removability of the Evolution® Esophageal fully covered stent.  
Hypothesis testing will be performed using a prospectively defined performance goal. 
6  Statistical Considerations 
6.1 
Hypotheses to be Tested 
6.1.1 Hypothesis to be Tested in Patients with Attempted Endoscopic Stent Retrieval 
 
Null 
Hypothesis: The percentage of patients, in whom endoscopic retrieval is attempted after an 
indwell time of at least 7 days, but no more than 6 months, who have successful 
removal of the Evolution® Esophageal fully covered stent is less than or equal to 
the performance goal of 88%. 
 
H0: γ ≤ 88% 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 19 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
Alternative 
Hypothesis: The percentage of patients, in whom endoscopic retrieval is attempted after an 
indwell time of at least 7 days, but no more than 6 months, who have successful 
removal of the Evolution® Esophageal fully covered stent is greater than the 
performance goal of 88%. 
 
Ha: γ > 88% 
6.1.2 Hypothesis to be Tested in Patients with Benign Indications 
 
Null 
Hypothesis: The rate of clinical success in patients with benign indications is less than or equal 
to the performance goal of 80%. 
 
          H20: π ≤ 80% 
Alternative 
Hypothesis: The rate of clinical success in patients with benign indications is greater than the 
performance goal of 80%. 
H2a: π > 80% 
6.2 
Sample Size 
The study is designed to enroll a maximum of 130 patients to ensure that 58 patients have had an 
attempted endoscopic stent removal after an indwell time of at least 7 days, but no more than 
6 months, to evaluate the primary hypothesis (section 6.1).  Patients may be enrolled at up to 
15 investigative sites, with no requirements regarding the maximum or minimum number of 
patients able to be enrolled at any given site.  The performance goal for the primary endpoint is 
based on a literature search that included removal rates following stent placement for both 
benign and malignant indications.1-28  It is important to note that, although the indications for 
stent placement varied (i.e., benign, malignant), the literature demonstrates that successful 
removal of the stent is independent of indication.  The nearly identical rates of successful stent 
removal between stents placed for benign indications compared to malignant indications 
supports enrollment of patients with varied indications for stent placement within the current 
study. 
 
The rate of successful stent removal from literature was estimated to be 98%.1-28  With a 
clinically relevant margin of 10%, a performance goal of the rate of successful removal of the 
stent was established to be 88%.  Fifty-eight (58) patients with attempted stent removal will be 
necessary to assess the primary hypothesis (section 6.1.1), under an expected rate of successful 
stent removal of 98%, with a one-sided exact binomial test, at a type I error rate of 0.025 and a 
power of 0.8.  Cook intends to enroll a maximum of 130 patients to ensure that 58 patients have 

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COMPANY CONFIDENTIAL 
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had an attempted endoscopic stent removal after an indwell time of at least 7 days, but no more 
than 6 months. 
 
The clinical success rate from literature was estimated to be 90% in patients with benign 
indications.29-31  With a clinically relevant margin of 10%, a performance goal of the clinical 
success rate was established to be 80%.  One hundred and seven (107) patients with benign 
indication will be necessary to assess the hypothesis (section 6.1.2), under an expected success 
rate of 90% at 7-day post-stent follow-up, with a one-sided exact binomial test, at a type I error 
rate of 0.025 and a power of 0.8. 
6.3 
Missing Data 
The first 58 patients with data submitted regarding attempted endoscopic stent removal will be 
used for hypothesis testing.   Appropriate summary statistics will be presented for the 58 patient 
cohort, as well as all the enrolled patients when appropriate, based on available data.  Patient 
withdrawals and lost to follow-up will be tabulated and assessed for their potential impact on the 
study results.  Specifically, if any patients withdraw or become lost to follow-up prior to the 
analysis of the 58 patients with stent removal, then the primary endpoint will be examined for the 
sensitivity of the results on these missing data via tipping point analysis.  Cook plans to enroll at 
least 110 patients with benign indications to account for possible withdrawal or lost to follow-up 
prior to the evaluation of clinical success at the 7-day post stent follow-up visit.  It is expected 
that 110 patients with benign indications can be enrolled by the time 58 patients have had an 
attempted endoscopic stent removal after an indwell time of at least 7 days, but no more than 
6 months. 
6.4 
Site-level Poolability 
At the final analysis, poolability of data from multiple sites will be verified by examining the 
primary and secondary endpoints among sites as well as important patient baseline 
characteristics.  Site-level poolability will be considered appropriate provided that these 
measures are similar among sites. 
 
It is expected that some sites may have too few patients to provide reasonable site-level estimates 
of primary, secondary, and baseline measures.  Pooling of this information will be explored 
based on hospital size (large versus small), site enrollment (large versus small), type of hospital 
(community versus teaching), and other group-wise strategies. 
 
It is recognized that patient baseline characteristics may differ among sites, with some sites 
routinely treating patients with more severe disease progression.  It is anticipated that the 
primary and secondary endpoint measures may be related to covariates that reflect this disease 

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progression, which are in turn related to outcome.  Thus, observed site-specific differences 
among the primary or secondary endpoints will be checked for confounding with other measured 
covariates (e.g., age, sex).  This can be accomplished using regression models (linear and logistic 
where appropriate) that include site and other measured covariates as independent variables. 
 
Should one or more sites be found to differ significantly from the rest, then subsequent analyses 
may include the discriminating covariate or a covariate to distinguish between the unusual site(s) 
and those sites that are considered poolable. 
6.5 
General Analysis 
The first 58 patients with attempted endoscopic stent removal (see Appendix C for definition) 
after an indwell time of at least 7 days, but no more than 6 months, will be included in 
hypothesis testing.  It is recognized that additional patients enrolled prior to the 58th attempted 
endoscopic stent removal may also have stent removal attempted prior to exiting the study.  
Those additional patients will be followed until reaching a study endpoint; however, these 
patients will not be initially included in the hypothesis testing.  A secondary successful removal 
analysis, which will include only patients in whom removal is attempted specifically by grasping 
the green lasso or other portion of the stent with the intention to remove the stent, will be 
conducted. A hypothesis on clinical success will also be tested in patients with benign 
indications when enrollment is complete and at least 110 patients with benign indications have 
reached their 7-day post stent follow-up. 
 
Secondary endpoints may be analyzed separately and/or together for those patients with 
attempted stent removal compared to those patients without attempted stent removal. 
Additionally, a subgroup analysis will be conducted on patients who undergo stent removal due 
to a lack of effectiveness (i.e., stent did not provide sufficient dysphagia relief or did not allow 
oral intake). 
 
Descriptive summaries will be provided where appropriate for each of the primary and secondary 
variables.  In general, summaries will be complete over the total population.  Continuous 
variable summaries will include the number of subjects (N), mean, standard deviation, minimum, 
and maximum.  Categorical variable summaries will include the frequency and percentage of 
subjects who are in the particular category.  In general, the denominator for the percentage 
calculation will be based upon the total number of subjects with the measurement for the total 
population and by treatment group, unless otherwise specified. 

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6.6 
Limitations of the Investigation 
The study is limited by the small sample size, but allows for calculations of appropriate summary 
statistics.  There is also the possibility that patients will reach study completion of data collection 
prior to stent removal, due to one of the events described in Section 7.10 (e.g., death, withdrawal, 
reached 6 months without stent removal).  These patients will not be included in the primary 
hypothesis testing. 
7  Methods 
7.1 
Subject Consent 
Patients who meet one of the inclusion criteria and none of the general exclusion criteria will be 
invited to participate in this investigation.  All patients eligible for entry into the investigation 
will have the clinical investigation plan explained to them, as well as potential risks and benefits 
of their participation in the investigation.  Each patient who agrees to participate will be required 
to sign an informed consent document prior to the procedure.  A baseline evaluation to collect 
data should include, but is not limited to, symptoms of the condition (e.g., pain, nausea), 
applicable past or current medical conditions, and patient’s dysphagia score.  Some 
inclusion/exclusion criteria (e.g., Endoscopically-confirmed Exclusion Criteria) may require 
evaluation immediately prior to stent placement to confirm eligibility into the study. 
7.2 
Medications 
Pre-procedural, procedural, and post-procedural/discharge medication and therapy should be 
based upon clinical indication and underlying disease (i.e., standard of care).  Information 
regarding use of acid suppression therapy and tumor reduction therapy should be captured at 
baseline, discharge, and throughout follow-up. 
7.3 
Stent Placement Procedure 
Please refer to the manufacturer’s IFU for stent and delivery system instructions, including 
general use information, patient preparation, procedural needs, wire guide use and selection, 
stent size selection, stent expansion/stent deployment, and delivery system removal.  Dilation 
should be completed, as necessary, to allow complete evaluation of the lesion prior to delivery of 
the stent.  Confirmation that the patient meets one applicable inclusion criterion, and none of the 
exclusion criteria (including General and Endoscopically-confirmed Exclusion Criteria), must be 
obtained prior to introduction of the stent.  The IFU recommends assessment and pre-dilation of 
the stricture, as necessary, to a diameter at least equal to the diameter of the delivery system and 
a maximum of 11 mm.  Pre-dilation can occur over several sessions per the physician’s 
discretion prior to stent placement.  There is a lasso loop with a grasping feature on both ends of 

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the stent to allow repositioning of the stent during the procedure, if needed (e.g., in the event of 
incorrect placement).  If clinically indicated, supplemental fixation may be used. 
 
At the time of the stenting procedure, the following information should be recorded, at a 
minimum: 
• Lesion characteristics 
• Stent information 
• Reason/indication for stent placement 
• Ability to deliver and accurately place the stent 
• Device integrity 
• Need for repositioning (note: repositioning within 24 hours does not necessarily reflect 
poorly on ability to deliver and accurately place the stent or ease of deployment as the stent 
is designed to allow for repositioning) 
• Adverse events (including serious events) occurring during the procedure 
7.4 
Point of Enrollment 
Point of enrollment will be based on the intent-to-treat population, and is defined to include any 
patient for whom the treatment procedure is initiated.  More specifically, once the delivery 
system of the study device (Evolution® Esophageal Stent System – Fully Covered) has been 
inserted into the patient, this patient would be included in the intent-to-treat population.  Cook 
intends to enroll a maximum of 130 patients to ensure that 58 patients have had endoscopic stent 
removal attempted after an indwell time of at least 7 days, but no more than 6 months.  The first 
58 patients with attempted endoscopic stent removal after an indwell time of at least 7 days, but 
no more than 6 months, will be included in hypothesis testing.  Additional analyses on remaining 
endpoints may be performed on all enrolled patients, as applicable, including an analysis on 
clinical success of the stent in benign conditions. 
7.5 
Post-stent Placement Procedure and Discharge 
Patients should be observed for development of any complications of endoscopy procedures, 
esophageal dilation, or stent placement.  Patients being treated for fistula, perforations, and leaks 
should have no fluids or foods by mouth until confirmation has been obtained that the stent has 
provided a successful seal (e.g., barium swallow).  It is recommended that patients be given clear 
liquids in an upright position during the first 24 hours.  After 24 hours, it is recommended that 
patients be instructed to chew food well or eat soft food and to drink fluids before and after 
meals. 
 

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Patients with stents placed in the distal esophagus or across the gastroesophageal (GE) junction 
may be instructed to elevate the head of their bed, and may be prescribed acid suppression 
therapy to minimize gastric reflux into the stent. 
 
Patients should be discharged according to institutional standards.  At the time of discharge, 
information including, but not limited to clinical symptoms (e.g., pain, nausea) and adverse 
events (including serious events) occurring since the procedure should be recorded. 
 
7.6 
Follow-up Post-stent Placement 
Patients will be followed after stent placement according to the schedule below unless the stent is 
removed (surgically or endoscopically), a non-study stent is placed, or other study exit (e.g., 
death, withdrawal, lost to follow-up) has occurred: 
 
Clinic visit 
7 days  (range 5-12 days) 
 
 
Telephone 
1 month ± 7 days 
 
 
 
2 months ± 7 days 
 
 
 
3 months ± 7 days  
 
 
 
4 months ± 7 days 
 
 
 
5 months ± 7 days 
 
 
 
6 months ± 7 days 
 
If a patient completes a required visit outside of the prescribed follow-up window, it will be 
recorded as a deviation from the clinical investigation plan. 
 
Patients enrolled in the study will be followed an additional 30 days following endoscopic stent 
removal, unless replaced with another non-study stent.  If the study stent is surgically removed 
(e.g., during esophagectomy), the patient will immediately exit the study.  If a non-study stent is 
placed (either before or after stent removal), the patient will immediately exit the study  (note: 
overlapping stents is not recommended per the IFU).  If the stent removal procedure occurs at the 
6- month follow-up, patients will be followed an additional 30 days following the stent removal 
procedure.  The data collection schedule is provided in Table 2. 
 
For all telephone contacts, a prescribed script is recommended to collect the required data.  At 
least three attempts to contact the patient should be made and documented in the study source 
documents.  If the patient still cannot be reached it may be considered a missed visit/telephone 
contact.  Of note, data may be collected at a clinic visit instead of a telephone call if preferred by 
the patient and/or physician. 

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Table 2. Data collection schedule 
Data collection 
schedule1  
Pre-procedure 
Stent placement 
procedure/discharge 
7-day2 
(5-12 days) 
1-month2 
(23-37 days) 
2-month2 
(53-67 days) 
3-month2 
(83-97 days) 
4-month2 
(113-127 days) 
5-month2 
(143-157 days) 
6-month2 
(173-187 days) 
Stent removal 
30 days post-stent 
removal 
Informed Consent  X 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
Exclusion  
X 
X 
 
 
 
 
 
 
 
 
 
Medical History  
X 
 
 
 
 
 
 
 
 
 
 
Lesion 
Characteristics  
 
X 
 
 
 
 
 
 
 
 
 
Dysphagia Score  
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Endoscopy2  
 
X 
 
 
 
 
 
 
 
X 
 
Radiographic 
Assessment2 
 
X3 
 
 
 
 
 
 
 
X3 
 
Telephone 
Contact4  
 
 
 
X 
X 
X 
X 
X 
X 
 
X 
Clinic Visit4  
X 
X 
X 
 
 
 
 
 
 
X 
 
 
1 If a non-study stent is placed (e.g., inside the study stent or after study stent removal) or if the study 
stent is removed surgically, patient will exit the study immediately.  If study stent is completely removed 
endoscopically and not replaced, patient will be followed for 30 days.  If stent is not completely removed 
and non-study stent is not placed, patient will be followed until patient reaches 6-month follow-up or stent 
is completely removed. 
2 Additional endoscopy and/or radiographic assessment (e.g., X-ray) should be performed if clinically 
indicated (e.g., lack of marked improvement in dysphagia score, significant pain, suspected stent 
migration).  Additional X-rays may be warranted in patients at higher risk for migration. 
3 If stent placed for fistula, perforation, or leak, radiographic assessment (e.g., barium swallow) should be 
performed to confirm successful sealing of the lesion after stent implantation and to confirm lesion 
closure following stent removal. 
4 Patient will be requested to provide information regarding clinical symptoms (e.g., dysphagia) and 
adverse event information since the last contact, if applicable, during each telephone contact and clinical 
visit during the patient’s study participation.  Adverse events should also be reported upon awareness of 
the event if between telephone contacts and clinical visits. 
 
For patients with a fistula, perforation, or leak, documentation of the original lesion closure 
should be obtained following stent removal (e.g., barium swallow), even if the original lesion is 
not identified using endoscopy at stent removal. 
 

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Additional endoscopy and/or X-rays should be performed according to standard of care if 
clinical symptoms persist/recur (e.g., lack of marked improvement in dysphagia score, 
significant pain, suspected migration).  Additional X-rays may be warranted in patients at higher 
risk for migration (e.g., patients undergoing radiation/chemotherapy, patients with gastric 
surgery resulting in altered anatomy).  Symptoms resulting in additional endoscopies should be 
recorded as adverse events. 
 
At follow-up, the following information should be recorded, at a minimum: 
• Dysphagia score 
• Patient’s resumption of oral intake 
• Current clinical symptoms (e.g., pain, nausea) 
• Adverse events (including serious events) since last contact 
7.7 
Stent Repositioning 
A patient may have the stent repositioned, when it is clinically indicated (e.g. sub-optimal 
placement after initial placement procedure, resulting in patient pain or discomfort).  Please refer 
to the manufacturer’s IFU for information regarding stent repositioning.  There is a lasso loop 
with a grasping feature on both ends of the stent to allow stent repositioning.  If clinically 
indicated, supplemental fixation may be used after repositioning.  If the stent is repositioned, the 
patient will continue to be followed according to the study schedule.  
 
If the stent is repositioned after discharge, the following information should be recorded, at a 
minimum: 
• Reason for repositioning 
• Dysphagia score (prior to stent repositioning) 
• Ability to reposition stent in desired position 
• Device integrity 
• Adverse events (including serious events) since last contact and during procedure to 
reposition stent 
7.8 
Stent Removal 
Patients will have the stent removed when it is clinically indicated based on the physician’s 
clinical judgment.  Please refer to the manufacturer’s IFU for information regarding stent 
removal.  The indwell time may be different depending on the indication for stent implantation.  
For example, removal of stents following treatment for benign indications should be considered 
between approximately 6 and 12 weeks after implantation.  Removal of stents following 
treatment for malignant indications should be considered after discussion among the patient’s 
treatment team (e.g., consultation with the patient’s oncologist following successful chemo- or 

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radiation therapy).  There is a lasso loop with a grasping feature on both ends of the stent to 
allow stent removal.  If the stent is endoscopically removed, the patient will be followed for 
30 days post-stent removal unless a new, non-study stent is placed.  If the stent is removed 
surgically (e.g., during esophagectomy), the patient will exit the study immediately. 
 
If the stent is unable to be completely removed during the initial removal procedure, the patient 
will continue to be followed until the stent (or remainder of the stent) is removed, until an 
additional stent is implanted, or for 6 months after the initial stenting procedure, whichever 
comes first. 
 
If the stent is endoscopically removed, the following information should be recorded, at a 
minimum: 
• Reason for removal 
• Dysphagia score (prior to stent removal) 
• Ability to completely remove stent  
• Device integrity 
• Adverse events since last contact and during removal procedure (including serious events 
and visible tissue damage or hemorrhaging requiring immediate intervention) 
7.9 
Duration of Study and Subject Participation 
Patient recruitment should be completed within 24 months of initiating the study.  Follow-up 
data will continue to be collected for six months after stent deployment for each patient in the 
study, unless a patient exits the study as discussed below (reminder: the patient will be followed 
for an additional 30 days if the stent is removed at the 6-month follow-up). 
7.10 
Study Exit 
A patient will be considered to have exited the study when one of the following has occurred: 
• Voluntary withdrawal 
• Lost to follow-up  
• Death 
• 30 days post endoscopic stent removal 
• Stent is surgically removed (e.g., during esophagectomy) 
• Non-study stent is implanted (e.g., inside study stent or after study stent is removed)  
• 6 months if the stent has not been removed or replaced 
After a patient exits the study, the physician may continue to follow the patient per the 
institution’s standard of care.  No additional data will be submitted to the data coordinating 
center once a patient has exited the study. 

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7.11 
Criteria and Procedures for Withdrawal 
A patient may decide to withdraw from the investigation at any time either before or after 
undergoing the procedure without prejudice or loss of care.  The patient should notify the 
investigator of his/her desire to withdraw.  The investigator will notify the sponsor.  The 
investigator may also decide to withdraw the patient from the investigation at any time based on 
medical judgment.  In these instances, the appropriate study visit and study termination data 
should be submitted to the data coordinating center, and will include the reason why the patient 
has been withdrawn from the study. 
 
Patients who withdraw consent after treatment will be followed until the time of their 
withdrawal.  No patient will be removed from the study unless the patient has withdrawn his/her 
consent before treatment or no treatment was ever attempted. 
 
In the event a patient is lost to follow-up or cannot be contacted for post-treatment assessments, 
every effort will be made to locate the patient, and these efforts will be documented. If the 
patient cannot be located, a lost to follow-up entry will be submitted. 
8  Deviations from Clinical Investigation Plan 
Investigators are not allowed to deviate from this CIP without prior authorization by the sponsor 
except under emergency situations when necessary to preserve the rights, safety, and well-being 
of human subjects. 
 
Deviations (failures to follow requirements of the CIP) and non-compliances (failures to follow 
applicable regulations) will be recorded together with an explanation.  Deviations or non-
compliances that impact the rights, welfare, or safety of patients shall be reported to the sponsor 
and IRB as required and as soon as possible. 
 
If appropriate, corrective and preventive actions will be discussed by the sponsor, investigator, 
and/or the IRB to determine a suitable course of action. 
9  Data Collection and Reporting 
9.1 
Electronic Case Report Forms (eCRF system) 
Patient data will be collected and entered by the investigative site onto an electronic case report 
form (eCRF) through an electronic data capture (EDC) system.  This is a secure, web-based 
system, allowing those with permission to access data from any location at any time.  Source 
data are to be retained for data entered into the eCRF system.  Site personnel are required to have 

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unique login names and passwords in order to enter patient data.  In accordance with 21 CFR 
Part 11, the eCRF system creates a secure, computer-generated, time stamped audit trail to 
record the date and time of operator entries and actions that create, modify, or delete electronic 
records. 
9.2 
Data Reporting  
Progress reports and a final report at the conclusion of the clinical investigation will be submitted 
by the investigators and sponsor to the IRBs as required by local regulations. 
10  Data Management and Quality Assurance 
10.1 
Data Entry and Quality Assurance 
Each principal investigator or appropriately trained designee shall enter the clinical data into the 
electronic data capture system.  Investigators will provide all applicable clinical data and 
documentation to the sponsor.  Patient data and documents pertaining to the investigation will be 
kept and archived by the sponsor.  Data will be reviewed for missing data, data consistency, and 
reasonableness of responses.  Discrepancies will be resolved through a formal query process 
involving direct contact with investigators or research coordinators.  The data coordinating 
center is responsible for database management, data verification, and data archiving and 
retention. 
 
As needed to assist the sponsor in its research (e.g., during evaluation of an adverse event), data 
will be accessible to the sponsor, the participating investigators, the manufacturer, and 
companies or individuals the sponsor authorizes. 
10.2 
Data Monitoring Arrangements 
Written procedures for monitoring the investigation are maintained by the data coordinating 
center and can be found in Appendix B. 
11  Safety Monitoring and Procedures for Reporting Adverse Events 
11.1 
Safety Monitoring 
A Data Safety Monitoring Board (DSMB) consisting of independent physicians and at least one 
independent statistician, who are not investigators in the investigation, and who do not have a 
perceived conflict of interest with the conduct and administration of the investigation, will be 
convened on a regular basis to evaluate investigation progress and review adverse events.   
 

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Regularly scheduled review/monitoring of patient data will be conducted at the data coordinating 
center, in part, for identification of adverse events and assurance that they are correctly reported 
to the DSMB. 
11.2 
Adverse Event Reporting 
Adverse events are to be reported to the data coordinating center using the appropriate case 
report form.  In cases of adverse device effects or serious adverse events, completed forms 
should be submitted to the data coordinating center as soon as possible upon knowledge of the 
event. 
 
The data coordinating center will review the information submitted for possible reporting to the 
sponsor.  The sponsor shall, if required according to applicable regulations, report the event to 
the appropriate regulatory authority.  If indicated, all investigators and sites will be notified by 
the sponsor.  The investigator or designee will notify his/her IRB of applicable events according 
to institutional guidelines. 
12  Early Termination or Suspension of the Investigation 
Any decision to suspend enrollment or terminate the investigation will be made in conjunction 
with the sponsor, and the local IRB, if applicable.  If a decision to terminate the study is made, 
all patients already treated will be followed for the duration of their participation in the study.  
13  Ethical Considerations 
The investigator is responsible for obtaining approval of this clinical investigation by the 
relevant IRB at his/her associated institution; the investigation will not begin until approval of 
the IRB has been obtained.  The investigator is responsible for complying with requirements 
imposed by the IRB and/or regulatory authority.  Furthermore, the investigator will ensure that 
regulations concerning the conduct of clinical data collection and data protection are followed.  
14  Publication Policy 
Publication policy, rights, and obligations for this investigation have been negotiated, detailed, 
and defined in the Investigation Contractual Documents and Agreements with the investigation 
site and investigators. 
15  Trial Administration and Investigators 
Contact information for the sponsor, data coordinating center, and monitor are provided in 
Appendix A. 

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15.1 
Approvals and Agreements 
The sponsor, coordinating investigator, and principal clinical investigators for each site shall 
agree to this document and any modifications.  A justification for any modifications will be 
documented.  Approval and agreement will be indicated by signing and dating the CIP signature 
page. 
15.2 
Investigators 
A list including the coordinating investigator and principal clinical investigators along with their 
contact information and respective site information will be maintained at the data coordinating 
center and will be available upon request.  All contact information will be updated periodically 
and maintained by the data coordinating center. 
15.3 
Insurance 
Insurance for the study will be obtained by the sponsor prior to enrollment of the first patient. 
16  References 
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expandable metal stents from the esophagus (with video). Gastrointest Endosc. 2011; 
74(1):44-50. 
[2] Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding 
metal esophageal stent: feasibility, technique of removal, and tissue response in 
humans. Am J Gastroenterol. 2009;104(6):1374-81. 
[3] Hirdes MM, Siersema PD, Vleggaar FP. A new fully covered metal stent for the 
treatment of benign and malignant dysphagia: a prospective follow-up study. 
Gastrointest Endosc. 2012;75(4):712-8. 
[4] Choi EK, Song HY, Kim JW, Shin JH, Kim KR, Kim JH, et al. Covered metallic stent 
placement in the management of cervical esophageal strictures. J Vasc Interv Radiol. 
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[5] Bakken JC, Wong Kee Song LM, de Groen PC, Baron TH. Use of a fully covered self-
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[6] Eloubeidi MA, Talreja JP, Lopes TL, Al-Awabdy BS, Shami VM, Kahaleh M. Success 
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expandable metal stents for benign esophageal diseases (with videos). Gastrointest 
Endosc. 2011;73(4):673-81. 

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[7] Lui J, Hu Y, Cui C, Li Y, Lin X, Fu J. Removable, fully covered, self-expandable metal 
stents for the treatment of refractory benign esophagogastric anastomotic strictures. 
Dysphagia. 2012;27(2):260-64.  
[8] Buscaglia JM, Ho S, Sethi A, DiMaio CJ, Nagula S, Stavropoulos SN, et al. Fully 
covered self-expandable metal stents for benign esophageal disease: a multicenter 
retrospective case series of 31 patients. Gastrointest Endosc. 2011;74(1):207-11. 
[9] Senousy BE, Gupte AR, Draganov PV, Forsmark CE, Wagh MS. Fully covered 
Alimaxx esophageal metal stents in the endoscopic treatment of benign esophageal 
disease. Dig Dis Sci. 2010;55:3399-403. 
[10] Nguyen NT, Rudersdorf PD, Smith BR, Reavis K, Nguyen XMT, Stamos MJ. 
Management of gastrointestinal leaks after minimally invasive esophagectomy: 
conventional treatments vs. endoscopic stenting. J Gastrointest Surg. 2011;15(11): 
1952-60. 
[11] Inbar R, Santo E, Subchi AEA, Korianski J, Halperin Z, Greenberg R, et al. Insertion of 
removable self-expanding metal stents as a treatment for postoperative leaks and 
perforations of the esophagus and stomach. Isr Med Assoc J. 2011;13:230-33. 
[12] Choi SJ, Kim JH, Choi JW, Lim SG, Shin SJ, Lee KM, et al. Fully covered, retrievable 
self-expanding metal stents (Niti-S) in palliation of malignant dysphagia: long-term 
results of a prospective study. Scan J of Gastroent. 2011;46:875-80. 
[13] Talreja JP, Eloubeidi MA, Sauer BG, Al-Awabdy BS, Lopes T, Kahaleh M, et al. Fully 
covered removable nitinol self-expandable metal stents (SEMS) in malignant stricutres 
of the esophagus: a multicenter analysis. Surg Endosc. 2012 26(6):1664-69. 
[14] Siddiqui AA, Sarker A, Beltz S, Lewis J, Loren D, Kowalski T, et al.  Placement of 
fully covered self-expandable metal stents in patients with locally advanced esophageal 
cancer before neoadjuvant therapy. Gastrointest Endosc. 2012;76(1):44-51. 
[15] Gallo A, Pagliuca G, de Vincentiis M, Martellucci S, Iallonardi E, Fanello G, et. 
Endoscopic treatment of benign and malignant strictures of the cervical esophagus and 
hypopharynx. Ann Otol Rhinol Laryngol. 2012;121(2):104-9. 
[16] van Boeckel PG, Dua KS, Weusten BL, Schmits RJ, Surapaneni N, Timmer R, et al. 
Fully covered self-expandable metal stents (SEMS), partially covered SEMS and self-
expandable plastic stents for the treatment of benign esophageal ruptures and 
anastomotic leaks. BMC Gastroenterol. 2012;12:19. 
[17] Battersby NJ, Bonney GK, Subar D, Talbot L, Decadt B, Lynch N. Outcomes following 
oesophageal stent insertion for palliation of malignant strictures: A large single centre 
series. J Surg Oncol. 2012;105(1):60-5.  

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
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CIP 11-012-04 ∙ 11 November 2013 
[18] Pellen MG, Sabri S, Razack A, Gilani SQ, Jain PK. Safety and efficacy of self-
expanding removable metal esophageal stents during neoadjuvant chemotherapy for 
resectable esophageal cancer. Dis Esophagus. 2012;25(1):48-53. 
[19] Freeman RK, Vyverberg A, Ascioti AJ. Esophageal stent placement for the treatment of 
acute intrathoracic anastomotic leak after esophagectomy. Ann Thorac Surg. 
2011;92(1):204-8; discussion 208. 
[20] Buscaglia JM, Jayaraman V, Nagula S. Temporary use of a new fully-covered self-
expanding metal stent for the management of post-esophagectomy strictures. Dig 
Endosc. 2011;23(2):187-9. 
[21] Bona D, Laface L, Bonavina L, Abate E, Schaffer M, Ugenti I, et al. Covered nitinol 
stents for the treatment of esophageal strictures and leaks. World J Gastroenterol. 
2010;16(18):2260-64. 
[22] Lopes TL, Eloubeidi MA. A pilot study of fully covered self-expandable metal stents 
prior to neoadjuvant therapy for locally advanced esophageal cancer. Dis Esophagus. 
2010;23(4):309-15. 
[23] Babor R, Talbot M, Tyndal A. Treatment of upper gastrointestinal leaks with a 
removable, covered, self-expanding metallic stent. Surg Laparosc Endosc Percutan 
Tech. 2009;19(1):e1-4. 
[24] Kim JH, Song HY, Choi EK, Kim KR, Shin JH, Lim JO. Temporary metallic stent 
placement in the treatment of refractory benign esophageal strictures: results and 
factors associated with outcome in 55 patients. Eur Radiol. 2009;19(2):384-90. 
[25] Kim JH, Song HY, Shin JH, Jung HY, Kim SB, Kim JH, et al. Membrane degradation 
of covered stents in the upper gastrointestinal tract: frequency and clinical significance. 
J Vasc Interv Radiol. 2008;19(2 Pt 1):220-4. 
[26] Zisis C, Guillin A, Heyries L, Lienne P, D'Journo XB, Doddoli C, et al. Stent 
placement in the management of oesophageal leaks. Eur J Cardiothorac Surg. 
2008;33(3):451-6. 
[27] Ko HK, Song HY, Shin JH, Lee GH, Jung HY, Park SI. Fate of migrated esophageal 
and gastroduodenal stents: experience in 70 patients. J Vasc Interv Radiol. 
2007;18(6):725-32. 
[28] Song HY, Park SI, Jung HY, Kim SB, Kim JH, Huh SJ, et al. Benign and malignant 
esophageal strictures: treatment with a polyurethane-covered retrievable expandable 
metallic stent. Radiology. 1997;203(3):747-52. 
[29] Karbowski M, Schembre D, Kozarek R, Ayub K, Low M. Polyflex self-expanding, 
removable plastic stents: assessment of treatment efficacy and safety in a variety of 
benign and malignant conditions of the esophagus. Surg Endosc. 2008;22:1326–1333. 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
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COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
[30] Vleggaar FP, Siersema PD. Stents for benign esophageal strictures. Techniques in 
Gastrointestinal Endoscopy. 2010;12(4):231-236. 
[31] Van Boeckel PG, Sijbring A, Vleggaar FP, Siersema PD. Systematic review: temporary 
stent placement for benign rupture or anastomotic leak of the oesophagus. Aliment 
Pharmacol Ther. 2011;33:1292-301. 
[32] Ogilvie AL, Dronfield MW, Ferguson R, Atkinson M. Palliative intubation of 
oesophagogastric neoplasms at fibreoptic endoscopy. Gut. 1982;23:1060-67. 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 35 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
APPENDIX A 
Contact Information 
Sponsor 
MED Institute, Inc. 
1 Geddes Way 
West Lafayette, IN 47906 
 
 
Contact: 
Jennifer Kerr, MS, CCRA, RAC 
 
Telephone: 
765.463.7537 
 
Fax: 
 
765.497.0641 
 
E-mail: 
jkerr@medinst.com 
 
Manufacturer 
Cook Ireland LTD. 
O’Halloran Road 
National Technology Park 
Limerick, Ireland 
 
Contact:  
Jacinta Kilmartin 
Telephone: 
+353 61 239483 
 
Fax: 
+353 61 239293 
E-mail: 
Jacinta.Kilmartin@CookMedical.com 
 
 
Data Coordinating Center 
MED Institute, Inc. 
1 Geddes Way 
West Lafayette, IN  47906 
 
Contact: 
Maureen (Cutler) Timko, RAC 
 
 
 
Scott Snyder, PhD 
Telephone:  
765.463.7537 
Fax: 
 
765.497.0641 
E-mail: 
mcutler@medinst.com  
 
 
 
ssnyder@medinst.com 
   
Monitor 
MED Institute, Inc. 
1 Geddes Way 
West Lafayette, IN 47906 
 
 
Contact: 
Jennifer Kerr, MS, CCRA, RAC 
 
Telephone: 
765.463.7537 
 
Fax: 
 
765.497.0641 
 
E-mail: 
jkerr@medinst.com  
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 36 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
APPENDIX B 
Written Procedures for Monitoring Clinical Investigations 
 
A. 
Selection of the monitor. 
Designated by the sponsor to oversee the investigation, the monitor may be an employee 
of Cook, an employee of a monitoring organization (CRO), or an independent contractor 
or consultant.  The monitor shall be qualified by training and experience to monitor the 
investigation in accordance with all applicable regulations and standards for conducting 
clinical investigations. 
 
B. 
General duties of the monitor. 
The monitor must ensure that the investigation is conducted in accordance with: 
1. 
The signed investigator agreement. 
2. 
The clinical investigation plan (CIP). 
3. 
Any conditions imposed by the IRB or regulatory authority. 
4. 
The requirements of the applicable regulations and standards. 
 
C. 
Reports by the monitor to the sponsor. 
1. 
Any non-compliance with the items listed above.  In the event that the 
investigator is not complying with the requirements outlined above, it is the 
sponsor’s responsibility to secure compliance. 
2. 
Any adverse events or effects that are potentially reportable to a regulatory 
authority. 
 
D. 
Initiating the investigation. 
Prior to initiating any clinical use of the device, the monitor or sponsor representative 
will participate in a pre-investigation or initiation visit with each investigative site.  
At a minimum, the following items shall be addressed during the site initiation visit: 
• 
Provide training to investigator on his/her responsibilities per the investigator 
agreement, applicable laws, regulations, and standards; and 
• 
Provide training to investigator that the IRB approval letter and informed 
consent/patient information is on file before initiation of the clinical investigation. 
Additionally, training may be provided to the investigator on: 
• 
The regulatory status of the device/product(s) and the requirements for the 
accountability of same;  
• 
The nature of the CIP; 
• 
The requirements for an adequate and well-controlled clinical investigation; 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
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COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
• 
His or her obligation to obtain informed consent in accordance with applicable 
regulations; 
• 
His or her obligation to ensure continuing review of the clinical investigation by the 
IRB in accordance with conditions of approval and applicable regulations and to 
keep the sponsor informed of such IRB approval and subsequent IRB actions 
concerning the investigation; 
• 
The importance of access to an adequate number of suitable subjects to conduct the 
investigation; 
• 
The importance of adequate facilities for conducting the clinical investigation; and 
• 
The importance of sufficient time from other obligations to carry out the 
responsibilities to which the investigator is committed by applicable regulations. 
 
E. 
During the course of the investigation, at the direction of the Project Manager, the 
monitor should visit the site frequently enough to ensure that: 
• 
The facilities and research staff used by the investigator continue to be acceptable for 
purposes of the clinical investigation; 
• 
The applicable version of the CIP and agreements are being followed; 
• 
Changes to the CIP, informed consent/patient information have been approved by 
the IRB and/or reported to the sponsor and the IRB; 
• 
Accurate, complete, and current records are being maintained; 
• 
Accurate, complete, and timely reports are being made to the sponsor and IRB; and 
• 
The investigator is carrying out the agreed-upon activities and has not delegated 
them to other previously unspecified staff. 
As appropriate, the following tasks could be performed during periodic visits:  
• 
Device/product accountability review; 
• 
Adverse event review to ensure that events are appropriately reported within the time 
periods required by the sponsor, CIP, IRB, and applicable regulatory requirements; 
and 
• 
Source data verification per the monitoring plan to determine that: 
o 
Informed consent/patient information has been documented in accordance with 
applicable regulations and expectations of the local IRB; 
o 
The information recorded in the case report forms (paper or electronic) is 
complete, accurate, and legible; 
o 
There are no omissions in the CRFs of specific data elements, such as the 
administration to any patient of concomitant test articles or the development of 
an intercurrent illness; 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 38 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
o 
Missing visits or examinations are noted; and 
o 
Subjects failing to complete the clinical investigation and the reason for each 
failure are noted. 
 
F. 
Records of the monitor. 
The monitor shall prepare and maintain records of each initiation visit and each periodic 
visit, general site contact, or discussion.  These will include: 
1. 
Date, name, and address of the investigator, and names of other staff members 
present at each meeting. 
2. 
A summary of the findings of the visit. 
3. 
A statement of any action taken by the monitor or investigator to correct any 
deficiencies noted. 
4. 
The monitor shall immediately notify the sponsor of any conditions of non-
compliance with the CIP, conditions of IRB or regulatory authority approval, or 
the applicable regulations. 
 
 
 
 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 39 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
APPENDIX C 
Definitions 
Attempted stent removal/retrieval: an endoscopic procedure in which one of the following 
occurs: 
1) Removal is attempted by grasping the green lasso or other portion of the stent with the 
intention to remove the stent, or 
2) Removal is intended, but the subject is not considered to be a candidate for safe 
endoscopic stent removal (i.e. endoscopic removal is felt to be not possible or not safe) 
 
Clinical success, for patients with obstruction caused by an intrinsic or extrinsic 
malignancy or patients with a refractory benign esophageal stricture: improvement or relief 
of dysphagia symptoms at the 7-day post-stent follow-up 
 
Clinical success, for patients with a fistula, perforation, or leak: seal sufficient to enable oral 
intake at the 7-day post-stent follow-up 
 
Dysphagia score:32  
 
 0 = able to eat a normal diet 
 
 1 = able to eat some solid food 
 
 2 = able to eat some semi-solid food only 
 
 3 = able to swallow liquids only 
 
 4 = inability to tolerate any oral intake 
Significant dysphagia ≥ 2 
 
Dysphagia, improvement: a decrease in the dysphagia score by at least 2 
 
Dysphagia, relief: complete relief of dysphagia (i.e., dysphagia score of 0) 
 
Stent migration: migration of the stent such that it is no longer covering treated lesion   
 
Stent removal-related adverse events: an adverse event directly related to the endoscopic 
removal of the stent.  These events include esophageal perforation, esophageal tears, and 
esophageal bleeding requiring immediate intervention.  If these conditions were present prior to 
stent placement, any worsening due to stent removal would be considered related to the removal 
procedure.  However, an adverse event identified during the removal procedure that was not 
caused specifically by removing the stent will be reported separately.  For example, an ulceration 
or perforation that arose during implantation would not be considered as associated with 

CLARITY – Evolution® Esophageal Stent System – Fully Covered 
MED Institute, Inc. 
 
Page 40 of 40 
 
COMPANY CONFIDENTIAL 
CIP 11-012-04 ∙ 11 November 2013 
removal.  Also, events caused by either applying or removing a method of supplemental fixation 
will not be considered related to stent removal. 
 
Successful stent removal: one in which the Evolution® Esophageal fully covered stent 
1) Is completely removed from the patient during a single endoscopic procedure with the 
wire mesh integrity maintained such that the stent can be removed in one contiguous 
piece, and 
2) Has no tissue damage or hemorrhage visible during the retrieval procedure that is both: 
a. Related to endoscopic stent removal and 
b. Requires immediate treatment 
Of note, patients with successful endoscopic study stent removal who require replacement with 
another non-study stent will be considered a success within the study.  Stents that are removed 
surgically (e.g., during esophagectomy) will not be evaluated for successful stent removal.  Stent 
damage or tissue damage or hemorrhage that results from supplemental fixation will not count 
against successful stent removal and will be reported separately. 
 
Technical success: a stent successfully delivered and placed at its intended location at the end of 
the procedure (note: adjustments made during the procedure are not considered a technical 
failure) 
 
Definitions for the following terms are not provided in this CIP, but can be found in the 
applicable regulations: 
 
Adverse event 
Adverse device effect 
Device deficiency 
Serious adverse event 
Serious adverse device effect 
Unanticipated adverse device effect 
Unanticipated serious adverse device effect