A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts
Phase: NA
Conditions: Hemodialysis Access Failure
Sponsor: SurModics, Inc.

AVess FIH Study 
Protocol Number: SUR18-001 
Version 2.0: 15Jan2020 
Confidential 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and 
Performance of the Surmodics Drug Coated Balloon in the Treatment of 
Subjects with Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, 
Including Native or Synthetic Grafts (AVess FIH Study) 
 
 
CLINICAL PROTOCOL SUR18-001 
Version: 2.0 
Date: 15 January 2020 
 
 
Investigational Device: Surmodics SurVeil™ Drug Coated Balloon (SurVeil DCB) 
 
 
Sponsored By 
Surmodics, Inc. 
9924 West 74th Street 
Eden Prairie, MN 55344 USA 
 
This document contains confidential information for use only by investigators participating in the 
clinical study. This document should be maintained in a secure location and should not be copied 
or made available for review by unauthorized personnel. 

AVess FIH Study 
Protocol Number: SUR18-001 
Version 2.0: 15Jan2020 
Confidential 
 
 
Protocol Synopsis 
Sponsor 
Surmodics, Inc. 
Protocol Title 
A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the 
Surmodics Drug Coated Balloon in the Treatment of Subjects with Obstructive Lesions of 
Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts (AVess FIH Study) 
Protocol Number 
SUR18-001 
Test Device 
SurVeil™ Drug Coated Balloon (SurVeil DCB) 
Device Sizes 
Working 
Length 
(cm) 
Balloon 
diameter 
(mm) 
Balloon length (mm) 
Rate 
Burst 
Pressure 
(atm) 
Minimum 
Introducer 
40 
80 
135 
5.0 
X 
X 
14 
6Fr 
6.0 
X 
X 
12 
6Fr 
7.0 
X 
X 
10 
7Fr 
Indication 
The SurVeil DCB will be indicated for percutaneous transluminal angioplasty, after appropriate 
vessel preparation, of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. 
Study Design 
Prospective, multi-center, single arm, first-in-man feasibility study 
Study Size 
Up to 15 subjects will be enrolled in the study. At up to 3 sites in Australia, New Zealand and/or 
Europe. 
Study Population 
Subjects with obstructive lesion of native arm arteriovenous fistulae for hemodialysis intended 
with treatment with balloon angioplasty. 
Study Purpose 
To evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions 
of arteriovenous fistulae for hemodialysis. 
Study Endpoints 
Primary Endpoints: 
1. Target Lesion Primary Patency at 6 months post procedure 
Secondary Endpoints: 
1. Absence of all-cause death up to 30 days. 
2. Rate of device and procedure related adverse events through 30 days. 
3. Secondary Patency: defined as supporting hemodialysis with a pump speed of at least 
300ml/min through 6 months. 
4. Patency of Target Lesion as defined by duplex ultrasound at 30 days, 6 months, 9 
months and 1 year. 
5. Number of interventions required to maintain target lesion patency at 30 days, 6 
months, 9 months and 1 year. 
Statistical 
Considerations 
The sample size for this feasibility study is based on clinical considerations and not power 
requirements for a formal statistical hypothesis test. All calculated p-values will be nominal. The 
data from this FIH study will be utilized to inform the sample size for future larger studies. 
Inclusion Criteria 
1. Subjects must be ≥18 years of age. 
2. Native AV fistula has been created ≥60 days prior to the index procedure. 
3. AV fistula, located in the arm, has undergone one or more successful hemodialysis 
sessions. 

AVess FIH Study 
Protocol Number: SUR18-001 
Version 2.0: 15Jan2020 
Confidential 
 
 
 
 
4. Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by 
operator visual estimate. 
5. Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate. 
6. Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate. 
NOTE: Only 2 tandem lesions permitted. Tandem lesions must be able to be treated 
as a single lesion and separated by a gap of ≤30 mm. The total combined lesion length 
including the gap must be ≤120 mm in length by operator visual estimate. 
7. Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND 
pre-dilatation with a PTA balloon resulting in: 
a. Residual stenosis of ≤30%, AND 
b. Dissection ≤ Grade B 
8. Subject has provided written informed consent and is willing to comply with study 
follow-up requirements. 
9. Subject has a life expectancy of ≥1 year. 
Exclusion Criteria 
1. Subject has a synthetic AV graft. 
2. Determined by operator to have a lesion that prevents complete inflation of an 
angioplasty balloon. 
3. Presence of pseudoaneurysm or aneurysm requiring treatment at 
the lesion site. 
4. Target lesion is located <30 mm from any stent. 
5. Thrombosis of the access site 30 days prior to procedure. 
6. Surgical revision of the access site planned within 30 days of procedure. 
7. Blood coagulative disorder, sepsis, or current AV access infection (white blood count 
≥12,000). 
8. Known contraindication (including allergic reaction) or sensitivity to antiplatelet 
therapy, anticoagulation therapy or paclitaxel (mild to severe cases), that cannot be 
adequately managed with pre-and post-procedure medication. 
9. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of 
prednisone per day. 
10. Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post 
procedure. 
11. Myocardial infarction 30 days prior to procedure. 
12. Stroke or TIA 90 days prior to procedure. 
13. Women who are pregnant, breast-feeding or intend to become pregnant or men who 
intend to father children during the time of the study. 
14. Subject is participating in any other investigational study that has not completed 
primary endpoint(s) evaluation or that clinically interferes with the endpoint from this 
study. 
Subject screening 
and enrollment 
process 
Subjects with signed informed consent who meet ALL inclusion and NONE of the exclusion 
criteria and attempted treatment with investigational device will be considered enrolled into 
the study. 
Follow-up 
Schedule 
Preoperative, Intra-Procedure, Post-Procedure, 30 days and at 6, 12, 24, 36, 48, and 60 months. 
Enrollment and 
Study Duration 
The enrollment period is expected to last approximately 6 months and study duration is expected 
to be approximately 66 months from study initiation.