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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03734679




Registration number
NCT03734679
Ethics application status
Date submitted
5/11/2018
Date registered
6/11/2018
Date last updated
2/01/2019

Titles & IDs
Public title
Safety and Efficacy of the SurVeilâ„¢ Drug-Coated Balloon (AVess FIH)
Scientific 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
Secondary ID [1] 0 0
SUR18-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodialysis Access Failure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SurVeil Drug Coated Balloon

Experimental: Surveil drug coated balloon -


Treatment: Devices: SurVeil Drug Coated Balloon
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion Primary Patency - Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Absence of all-cause death
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Rate of device and procedure related adverse events
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Hemodialysis with a pump speed of at least 300 ml/min
Timepoint [3] 0 0
Through 6 months
Secondary outcome [4] 0 0
Subsequent reinterventions, such as angioplasty, stent, fistula, that are required to maintain target lesion patency
Timepoint [4] 0 0
30 days, 6 months, 9 months and 1 year
Secondary outcome [5] 0 0
Patency of target lesion as defined by duplex ultrasound
Timepoint [5] 0 0
30 days, 6 months, 9 months and 1 year

Eligibility
Key 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.

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.

7. Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire
AND pre-dilatation with a PTA balloon resulting in: residual stenosis of =30% and
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SurModics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in
subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
Trial website
https://clinicaltrials.gov/show/NCT03734679
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aaron Jacobson, DC, CCRP
Address 0 0
Country 0 0
Phone 0 0
651-366-2215
Fax 0 0
Email 0 0
ajacobson@surmodics.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable