Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Phase: PHASE3
Conditions: Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
Sponsor: Singapore General Hospital

 
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            STUDY PROTOCOL 
  
PROTOCOL TITLE:  
Randomised clinical trial comparing drug-coated balloon to plain balloon for all peripheral AVF 
stenosis   
  
PROTOCOL  
Version 1.0  
VERSION:   
PROTOCOL DATE:   
28 Dec 2022 
  
PRINCIPAL INVESTIGATOR:   
Dr Zhuang Kun Da, Consultant Interventional Radiology, Singapore General Hospital  
  
CO-INVESTIGATORS: 
Apoorva Gogna, Senior Consultant, Singapore General Hospital 
Nanda Kumar Karaddi Venkatanarasimha, Senior Consultant, Singapore General Hospital 
Tay Kiang Hiong, Senior Consultant, Singapore General Hospital 
Chan Ju Min Shaun Xavier, Senior Consultant, Singapore General Hospital 
Chandramohan Sivanathan, Senior Consultant, Singapore General Hospital 
Chua Ming Er Jasmine, Consultant, Singapore General Hospital 
Farah Gillan Irani, Senior Consultant, Singapore General Hospital 
Lee Kristen Alexa, Consultant, Singapore General Hospital 
Leong Sum, Senior Consultant, Singapore General Hospital 
Lo Hoau Gong Richard, Senior Consultant, Singapore General Hospital 
Loh Eu Kuang Stanley, Senior Consultant, Singapore General Hospital 
Patel Ankur, Senior Consultant, Singapore General Hospital 
Tan Bien Soo, Senior Consultant, Singapore General Hospital 
Tan Sheng Ming Alexander, Associate Consultant, Singapore General Hospital 
Tan Zehao, Associate Consultant, Singapore General Hospital 
Tashi Sonam, Consultant, Singapore General Hospital 
Toh Han Wei Luke, Visiting Consultant, Singapore General Hospital 
Too Chow Wei, Senior Consultant, Singapore General Hospital 
Wang Qi Wei Mark, Associate Consultant, Singapore General Hospital 
  
  
  
 
  
  
  

 
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Contents  
STUDY PROTOCOL ............................................................................................................................... 1 
1.  BACKGROUND AND RATIONALE ...................................................................................................... 3 
2.  STUDY OBJECTIVE ........................................................................................................................... 3 
3.  STUDY DESIGN ................................................................................................................................ 3 
4.  PRINCIPAL INVESTIGATOR ............................................................................................................. 4 
5.  STUDY OUTCOMES ........................................................................................................................... 4 
6.  ANALYSIS PLAN ............................................................................................................................... 5 
7.  SAMPLE SIZE CALCULATION FOR THE PRIMARY ANALYSIS ........................................................... 5 
8.  METHODS ......................................................................................................................................... 5 
9.  STUDY POPULATION ....................................................................................................................... 8 
10. IN AND EXCLUSION CRITERIA ....................................................................................................... 8 
11. EXPECTED STUDY PERIOD ............................................................................................................. 8 
12. INFORMATION TO BE COLLECTED ................................................................................................. 9 
13.  ETHICAL CONSIDERATIONS ......................................................................................................... 9 
14. SAFETY ......................................................................................................................................... 10 
16. SUPPORT REQUIREMENT FROM BSC: (STUDY CONDUCT BUDGET / DEVICE SUPPORT ............. 13 
17. COSTS NOT COVERED BY TRIAL ................................................................................................... 13 
18. LITERATURE/REFERENCES .......................................................................................................... 13 
 
  
  
  
  
  
 
 

 
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1.  
BACKGROUND AND RATIONALE  
  
Recent trials comparing drug-coated balloon (DCB) to plain balloon for the treatment of arteriovenous 
fistula (AVF) stenosis have demonstrated improved target lesion patency with the use of DCB (Table 1) 
[1–4].  
  
The common limitation of these studies is the selection of a single lesion in the AVF as the study lesion, 
leaving the other lesions (non-target) to be treated with plain balloon angioplasty. The earlier recurrence 
of non-target lesions not treated with DCB leads to repeat intervention and reduction in overall benefit of 
DCB.   
  
Therefore, while the use of DCB appears promising in treating a single AVF stenotic lesion, the access 
circuit patency (lost when repeat intervention is performed to any segment of the AVF) is not improved 
significantly in the DCB group. For instance, our locally conducted study reported improved target lesion 
patency through to 12 months (12-month target lesion patency: 51% vs 34%, p=0.04), but not for access 
circuit patency (12-month access circuit patency: 45% vs 32%, p=0.16). Similarly, Trerotola reported 
improved target lesion patency at 9 months, but access circuit patency showed no significant difference at 
all time points [2].   
  
The access circuit patency is the better and more meaningful outcome measure since it assesses the entire 
AVF circuit patency. The generalisability of these studies is therefore limited as it is common to have 
several lesions in the AVF circuit in the real-world. The true benefit of DCB in AVF interventions will be 
better assessed by treating all lesions with DCB and comparing the access circuit patency as the primary 
outcome measure.   
  
There is no trial to date that has studied DCB in this manner and the cost-effectiveness of this strategy, 
both of which remain important gaps in evidence across the Asian as well as the global patient 
population.  
  
  
2.  
Study Objective   
  
To determine if the use of DCB for all AVF stenosis provides a higher access circuit primary patency 
compared with plain balloon angioplasty alone.  
  
We hypothesise that use of DCB angioplasty for all peripheral AVF stenosis leads to improved access 
circuit primary patency at 6 months.    
  
3.  
Study Design  
  
We propose a prospective, single centre (Singapore General Hospital, Interventional Radiology Centre  
(IRC) and Interventional Nephrology Suite (INS)), multidisciplinary (Interventional Radiology, Vascular 
Surgery and Interventional Nephrology), randomised clinical trial comparing DCB to plain balloon for all 

 
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stenotic lesions, except central vein lesions, in failing mature AVF. Randomisation will be 1:1 and 
stratified by number of lesions (single versus multiple AVF stenoses).  
 
Study population and procedure location: 
Renal failure patients with malfunctioning AVFs referred to Singapore General Hospital for angioplasty 
will be assessed for eligibility and consent obtained by a team member. Both outpatient day surgery or 
inpatient referrals will be accepted for trial consideration. 
 
The trial procedure will be performed as a day surgery or inpatient procedure depending on the source of 
referral and relative urgency of procedure. Patients referred from an inpatient source may be performed as 
a day surgery case after discharge from the ward if the need for angioplasty is not time-sensitive (i.e. not 
impending thrombosis from very low AVF flow). 
The trial procedures will be performed in both Interventional Radiology Centre or Interventional 
Nephrology centre in Singapore General Hospital. 
 
  
4.  
Principal investigator  
  
Zhuang Kun Da, Consultant Interventional Radiologist, Singapore General Hospital.  
  
5.  
Study Outcomes  
  
Primary Outcomes  
• 
Access circuit primary patency at 6 months*  
  
Secondary Outcomes  
• 
Access circuit primary patency at 12 months  
• 
Access circuit assisted primary patency at 6 and 12 months  
• 
Access circuit secondary patency at 6 and 12 months  
• 
Number of repeat interventions at 12 months  
• 
Procedural complication rates  
• 
Mortality rates at 12 months and up to 5 years  
• 
Complications during follow up^  
  
The patency endpoints will be assessed clinically without routine fistulography or ultrasound. Clinically 
driven outcomes are favoured over routine imaging (fistulography / ultrasound) for the following reasons: 
scheduled imaging may lower patency due to the detection of asymptomatic AVF stenosis, prompting 
earlier treatments (that would have otherwise manifested only later); patients may decline to return for 
imaging follow up, resulting in missing data; and reduced study cost.  
  
* Patency definitions are based on SIR reporting standards (Gray et al., 2003):  
  
Primary patency is defined: interval following intervention until the next repeated access intervention.  
  

 
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Assisted primary patency is defined: interval following intervention until access thrombosis or a surgical 
intervention that excludes the treated lesion from the access circuit. Percutaneous treatments of either 
restenosis / occlusion of the previously treated lesion or a new arterial or venous outflow stenosis / 
occlusion (excluding access thrombosis) are compatible with assisted primary patency.   
  
Secondary patency is defined: interval following intervention until the access is surgically declotted, 
revised or abandoned because of inability to treat the original lesion or choice of surgeon.    
  
^Complications will be categorised according to SIR definitions of minor or major complications  
(Aruny et al., 2003)  
  
Major complication:  
1. 
require therapy, minor hospitalisation (< 48 hours),  
2. 
require major therapy, unplanned increase in level of care, prolonged hospitalisation (>48 hours),  
3. 
leads to permanent adverse sequelae, or  
4. 
death  
  
Minor complications:  
1. 
requires no therapy with no consequence,  
2. 
requires nominal therapy with no consequence; includes overnight admission for observation only.   
  
6.  
Analysis plan  
  
The 6-month access circuit primary patency (proportion) will be compared with the Fisher’s Exact test.  
Other patency data will be presented as Kaplan Meier survival curves and compared with logrank test. 
Categorical data will be presented as numbers and percentages, continuous data as means +/- standard 
deviation.   
  
7.  
Sample size calculation for the primary analysis  
  
Hypothesis:   
  
We hypothesise that DCB angioplasty for all peripheral AVF stenosis leads to improved access circuit 
patency compared to plain balloon angioplasty alone (80% vs 50%).   
  
Final sample size  
For the current study, assuming the 6 month access circuit patency of 50% in the control arm and expected 
patency of 80% in the active arm, power of 80% and two-sided α of 0.05, 86 patients are required in the 
study. Allowing for 10% dropout, a total of 94 patients will be recruited.  
  
8.  
Methods  
  
We will conduct an investigator initiated, partly industry sponsored (see budget), prospective, clinical trial 
at the Singapore General Hospital. The trial will be funded by a research grant from Boston Scientific. 

 
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Institutional Review Board approval will be obtained for the investigation protocol before start of the 
study. Informed consent will be obtained from all patients. In total, there will be 94 patients recruited. 
Patients with malfunctioning AVFs referred for percutaneous transluminal angioplasty (PTA) will be 
recruited and assessed for eligibility. Inclusion and exclusion criteria are detailed below (section 10).    
 
Randomisation: 
Randomisation will be performed via a web based system (RAND) in a 1:1 allocation ratio and stratified 
according to the number of AVF stenotic lesions (single versus multiple AVF stenotic lesions). AVF with 
multiple stenoses may have a worse outcome compared to AVF with single stenosis. Stratification will 
prevent an imbalance in the proportion of participants with multiple AVF stenosis in either study arm. 
 
Blinding: The participants and study team members, except for the protocol administrator and procedurist, 
will be blind to study arm allocation. It is not possible to blind the protocol administrator and procedurist 
as they will have to perform randomisation and handle the angioplasty balloon respectively during the trial 
procedure. Fluoroscopy images of the trial balloons will not be labelled to maintain blinding after the trial 
procedure. 
 
  
  
Study Procedure 
 
Diagnostic fistulogram 
All patients will undergo fistulogram of the AVF with a 22G cannula or sheath. The site, degree and length 
of the stenoses will be documented using digital measuring software available on the angiography 
machine. 

 
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Pre-dilatation 
All eligible AVF stenoses will be treated with conventional balloon of an appropriate size (similar size to 
or 1 mm larger than reference vessel diameter) up to rated burst pressure, with each inflation lasting at 
least 1 minute. The choice of conventional balloon is at the procedurist’s discretion. After angioplasty, 
fistulogram is performed to assess angiographic outcomes. In the presence of more than 30% residual 
stenosis after balloon angioplasty, repeat angioplasty with a larger plain balloon (in 1 mm increments) can 
be performed. 
In the event of inability to efface the balloon waist with a conventional plain balloon, a high-pressure 
balloon or cutting balloon may be used at the operator's discretion. 
The patient will be randomised into one of the two treatment arms after achieving less than 30% residual 
stenosis in the eligible AVF stenoses and exclusion of significant central vein stenosis. 
 
(1) Control arm (plain balloon): 
After allocation to the control arm, repeat angioplasty of the stenosis will be performed with the last used 
conventional (plain) balloon. Each inflation may be performed up to rated burst pressure and held for 3 
minutes. Repeat fistulogram will be performed after angioplasty to assess for final angiographic outcome. 
 
(2) Active arm (DCB): 
After allocation to the active (DCB) arm, a Ranger DCB of an appropriate length (exceeding either side of 
the AVF stenosis by at least 1 cm to prevent geographic miss) and size (similar to or 1 mm larger than 
reference vessel diameter) is inflated up to rated burst pressure and held for 3 minutes to allow satisfactory 
elution of drug into the vessel wall. Repeat fistulogram will be performed after angioplasty to assess for 
final angiographic outcome. 
 
Post-procedure monitoring and medication 
Post procedure monitoring will be performed according to established clinical practice. Patients will be 
monitored for at least 4 hours after procedure if it is performed as a day surgery case. Inpatient cases will 
be monitored in the wards after the procedure. 
All participants in both study arms, if not already on antiplatelet(s), will be started on 1 month of aspirin. 
Clopidogrel will be used in the event of aspirin allergy or intolerance. For participants already on 
antiplatelet agent prior to trial enrolment, no change will be made to the type or duration of existing 
antiplatelet treatment.  
 
Follow up (imaging):  
Clinically-driven angiography will be performed when there is dysfunction of the AVF such as poor flow 
or high recirculation. 
 
Follow up: 

 
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All study subjects will receive a phone call consultation at 6 and 12 months after procedure. Electronic 
medical records review will be used to determine mortality status at 5 years. 
  
9.  
Study Population  
  
In this single centre trial, 94 participants will be enrolled. Renal failure patients with malfunctioning AVFs 
referred to Singapore General Hospital for angioplasty will be assessed for eligibility and consent obtained 
by a team member. Both outpatient day surgery or inpatient referrals will be accepted for trial 
consideration. 
  
10.  Inclusion and exclusion criteria   
  
Inclusion criteria  
  
1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic 
abnormalities. Both de novo and recurrent stenosis are accepted.  
2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).  
3. Less than 30% residual stenosis after angioplasty. 
4. ≥ 21 years old  
5. Informed and valid consent given.   
  
  
  
  
  
Exclusion criteria  
  
1. Thrombosed AVFs  
2. Haemodynamically significant central vein stenosis  
3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)  
4. Contraindication to antiplatelet therapy  
5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural 
transfusion.  
6. Allergy / contraindication to paclitaxel.  
7. Acute infection over proposed puncture site.  
8. Women who are breastfeeding, pregnant * or planning on becoming pregnant during study.   
9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance 
with protocol.  
10. Currently participating in an investigational drug, biologic or device trial that may have an impact on 
the dialysis access or previous enrolment in this study.  
  
* Contraception and pregnancy testing: All female participants of child-bearing age are to use birth 
control up to 12 month after trial enrolment. A urine pregnancy test should be taken to exclude pregnancy 
prior to trial enrolment.  
  
  
11.  
Expected study period  
  
Enrolment: Start Jan 2023 – Finishing Dec 2024. 

 
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Expected study duration: Start Jan 2023 – Finishing Dec 2029 (after 5 year follow up) 
   
12.  Information to be collected  
  
1. Patient details: 
a. Age 
b. Gender 
c. Race 
d. Drug allergies 
e. Co-morbidities (diabetes mellitus, cerebrovascular disease, coronary artery disease, 
previous thromboembolic disease, hypertension, hyperlipidaemia, smoking, malignancy) 
2. AVF details: 
a. Date of access creation 
b. Location of access (above or below elbow) 
c. Side of access (right, left) 
d. Type of access (radiocephalic, brachiocephalic, brachiobasilic, others) 
e. Number and dates of prior endovascular treatments 
3. Procedure (both trial procedure and repeat procedure) details: 
a. Date of procedure 
b. Location of stenosis and presence of any new stenosis 
c. Pre-treatment AVF diameter and stenosis 
d. Length of stenosis (mm) 
e. Reference vessel diameter (mm) 
f. Date of prior angioplasty 
g. Balloon details (type, diameter, length, maximum inflation pressure, inflation duration) 
h. Post treatment residual stenosis, presence of rupture, stent deployment 
4. Follow up / Endpoint 
a. Adverse event surveillance 
b. Anti-platelet medication 
c. Access circuit patency at 6 and 12 months 
d. Number of repeat interventions at 12 months 
e. Mortality at 12 months and up to 5 years 
  
  
 
13.   
ETHICAL CONSIDERATIONS  
  
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki and that are consistent with the Singapore Good Clinical Practice and the 
applicable regulatory requirements.  
  
The Centralised Institutional Review Board (CIRB) must approve this final study protocol, including 
the final version of the Patient Information and Informed Consent Form, in writing, prior to enrolment 
of any patient into the study. The principle investigator is responsible for informing the CIRB of any 
amendments to the protocol or other study-related documents, as per local requirement.  
  

 
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Informed Consent  
Participation is voluntary and eligible subjects should be competent to understand the implications of 
participation in the study. Before enrolment, all patients will have to give their written informed 
consent. The centre’s local investigator ensures that the patient will be informed on the basis of the 
Informed Consent Form. If a patient is not capable of writing, informed consent can be given using a 
thumbprint or orally in the presence of at least one witness in accordance to the Medical Research 
Involving Human Subjects Act (article 6, subsection 2, altered WMO).  
  
Confidentiality of Data and Patient Records  
Information will be collected in hardcopy data collection forms which will form the source documents. 
The data will be entered into the electronic case report forms as soon as possible. Transcribed data in 
the electronic case report forms will be password-protected and access monitored. All investigators 
will ensure protections of subjects’ personal data and subject names or identifiers will not be included 
on any reports or publications from the study. The list containing the links between enrolment numbers 
of each subject to their identity will be kept under lock and key in the PI’s office, separate from the 
source documents. All hardcopy source documents will be archived for a duration of 7 years after the 
end of the study.  
  
Investigator Responsibilities   
The investigator is responsible for ensuring that the trial is conducted according to all signed 
agreements, the study protocol and good clinical practice (GCP) requirements.  
  
Quality control and quality assurance  
The investigators and their personnel filling the CRFs are responsible for filling the forms honestly and 
accurately.  All forms must be filled prospectively. Quality control checking mechanisms are 
implemented in the online CRF system to prevent entry of inconsistent variables. The Principal 
Investigator will ensure accuracy of the data.  
  
14. Safety  
  
Patients enrolled in this trial will be exposed to the same risks shared by all patients undergoing in 
routine clinical practice. All devices used in this trial will be approved devices in the enrolling 
centres/countries.  
  
Participants may encounter the “usual” risks associated with fistulogram and balloon angioplasty:  
  
• 
Pain or discomfort during treatment  
• 
Injury to the vessels (feeding artery, AVF and/or draining veins) leading to bleeding/hematoma 
generally can be controlled but may require surgery or stent(graft) and can lead to loss of AVF.  
• 
Thrombosis of the AVF (which may require thrombolysis or surgery but can lead to loss of 
AVF)  
• 
Infection  
• 
Mild to moderate allergic reaction to contrast.   
• 
Recurrence of the stenosis.   

 
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Uncommon or rare risk may be encountered:  
  
• 
Severe allergic reaction to contrast  
• 
Allergic reaction to heparin, including heparin induced thrombocytopenia  
• 
Allergic reaction to other medicine and equipment used during procedure  
• 
Allergic reaction to paclitaxel, aspirin and/or Plavix 
• 
Significant bleeding secondary to dual anti platelet therapy.   
• 
Loss of limb / amputation  
• 
Pulmonary embolus  
• 
Death 
  
15 ADVERSE EVENT REPORTING  
 
Standard definitions of adverse events will be used as follows:  
Adverse event (AE):  
Any untoward medical occurrence in a patient or clinical investigation subject which does not 
necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any 
unfavourable and unintended sign, symptom, or disease temporally associated with the use of a 
therapeutic product, whether or not related to the product.  
  
Adverse device effect (ADE)  
Adverse event related to the use of an investigational medical device, including any  
adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, 
the implantation, the installation, the operation, or any malfunction of the investigational medical 
device, and any event that is a result of a use error or intentional misuse.  
  
Serious AE (SAE) is an adverse event that:  
1. Led to death  
2. Led to a serious deterioration in the health of the subject that:  
a. resulted in a life-threatening illness or injury,  
b. resulted in a permanent impairment of a body structure or body function  
c. required in-patient hospitalization or prolongation of existing hospitalization  
d. resulted in medical or surgical intervention to prevent permanent impairment to a body structure or 
body function  
3. Based upon appropriate medical judgment, may jeopardize the subject’s health and may require 
medical or surgical intervention to prevent one of the other outcomes listed in this definition  
  
Unanticipated Adverse Device Effect (UADE)  
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the protocol or investigational plan, Investigator’s Brochure, or any 

 
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other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare 
of subjects.  
  
Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to CIRB 
The reporting requirements will be in accordance to the reporting requirements published on CIRB 
website at the time when the event took place. 
 
Only related SAEs (definitely/ probably/ possibly) will be reported to CIRB. Related means there is a 
reasonable possibility that the event may have been caused by participation in the clinical trial.   
 
The investigator is responsible for informing CIRB after first knowledge that the case qualifies for 
reporting. Follow-up information will be actively sought and submitted as it becomes available.  
 
Related AEs will not be reported to CIRB.  However, the investigator is responsible to keep record of 
such AEs cases at the Study Site File. 
 
Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to the Health Sciences 
Authority (HSA) 
 
The reporting requirements will be based on the reporting requirements published on HSA website at 
the time when the event took place. 
 
Collecting, Recording and Reporting of Reportable Adverse Events relating to Medical Device to 
the Health Sciences Authority (HSA) 
Adverse event (AE) in relation to human biomedical research means any untoward medical occurrence 
as a result of any human biomedical research which is NOT serious. Adverse event can be any 
unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease 
possibly/ probably/ definitely associated with the participant in the human biomedical research. 
 
The reporting requirements will be will be based on the reporting requirements published on HSA 
website at the time when the event took place. 
 
All adverse events relating to medical device which meets the three basic reporting criteria listed 
below, is considered as a reportable adverse event to HSA: 
• An AE (or potential AE) has occurred. 
• The medical device is associated with the AE. 
• The AE leads to one of the following outcomes: 
o It becomes a serious threat to public health. 
o The death of a patient, user or other person. 
o Serious deterioration in state of health of patient, user or other person. 
o There is no death or serious injury in the initial AE but it might lead to death or serious 
injury of a patient, user or other person if the AE recurs. 
 

 
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16 Support requirement from BSC: (Study conduct budget / Device support  
  
Device support  
  
• 
80 Ranger DEB balloons different lengths up to 8 cm, diameter 5- 8 mm on an 80cm shaft.  
• 
47 V18 0.018” 200cm wires  
  
Other expenses  
  
• 
0.5 FTE research coordinator for 2 years  
• 
Meetings / training /travelling for presentations.   
• 
Printing / stationary   
  
  
17 Costs not covered by trial  
  
• 
Basic procedure costs  
• 
High pressure balloons if necessary  
• 
Larger or smaller balloons if necessary (also for non-target lesions)  
• 
Stents/stent grafts if necessary  
• 
Any other equipment needed during procedure  
  
  
  
 
18.  
Literature/references  
  
1. Irani, F. G. et al. Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial 
Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty. Radiology 289, 238–247 
(2018).  
2. Trerotola, S. O., Saad, T. F. & Roy-Chaudhury, P. The Lutonix AV Randomized Trial of Paclitaxel-
Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis.  
Journal of Vascular and Interventional Radiology 31, 1-14.e5 (2020).  
3. Trerotola, S. O., Lawson, J., Roy-Chaudhury, P. & Saad, T. F. Drug Coated Balloon Angioplasty in 
Failing AV Fistulas: A Randomized Controlled Trial. Clinical Journal of the American Society of 
Nephrology 13, 1215–1224 (2018).  
4. Lookstein, R. A. et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N 
Engl J Med 383, 733–742 (2020).