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Trial registered on ANZCTR


Trial ID
ACTRN12614000094673
Ethics application status
Approved
Date submitted
18/12/2013
Date registered
24/01/2014
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Evaluation of the Cook Advance (Registered Trademark) Scoring Balloon in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuit
Scientific title
Clinical Evaluation of the Advance (Registered Trademark) 35 Scoring Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter in treating stenoses of a mature native arteriovenous (AV) hemodialysis access circuit
Secondary ID [1] 283258 0
None
Universal Trial Number (UTN)
Trial acronym
ADVANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stenoses of a mature native arteriovenous (AV) hemodialysis access circuit 290134 0
Condition category
Condition code
Renal and Urogenital 290521 290521 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Advance Scoring Balloon is a balloon catheter used to perform angioplasty in narrowed blood vessels. In this study it is used to treat narrowing of a hemodialysis fistula in order to improve the effectiveness of dialysis. Angiography and intravascular ultrasound will be used during the procedure to examine the effectiveness of the study procedure. The procedure should take approximately 45 minutes. After the procedure, participants are required to complete follow-up visits at 1, 3, and 6 months to undergo clinical assessment. An angiogram will also be performed at 3 and 6 months post-procedure.
Intervention code [1] 287990 0
Treatment: Devices
Comparator / control treatment
No comparator/control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290543 0
Procedural peformance of the device, specifically:
1. Extent of residual stenosis (less than 30 %) within the treated lesion immediately after angioplasty, assessed by angiography
2. Inflation pressure of scoring balloon, measured using a balloon inflation device with atmospheric pressure guage
3. Adverse events, e.g. aneurysm; vessel dissection, perforation, rupture or injury; pain and/or discomfort at stenosis during treatment; hematoma
Timepoint [1] 290543 0
Throughout the duration of the procedure and immediately after the procedure.
Primary outcome [2] 290544 0
Short term perfomance of the device assessed by resumption of normal dialysis and target lesion patency at 6 months post-procedure.
Resumption of normal dialysis will be assessed by obtaining dialysis treatment information on the patient following the study procedure.
Target lesion patency will be assessed based on continued successful dialysis treatment, need for re-intervention or abandonment of access site, and angiography at 6 months.
Timepoint [2] 290544 0
6 months post-procedure
Secondary outcome [1] 304846 0
Short term perfomance of the device assessed by target lesion patency at 1 and 3 months post-procedure.
Target lesion patency will be assessed based on continued successful dialysis treatment, need for re-intervention or abandonment of access site, and angiography at 3 months (angiography not performed at 1 month).
Timepoint [1] 304846 0
1 and 3 months post-procedure

Eligibility
Key inclusion criteria
1. A greater than 50% stenosis (when compared to the reference vessel diameter) of a mature native AV dialysis access circuit in the upper extremity
2. Clinical or physiological abnormalities which indicate dialysis access dysfunction
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any related surgical or interventional procedure of the access circuit less than or equal to 30 days prior to the enrollment
2. Medical condition or comorbid conditions that would limit life expectancy to less than 6 months
3. Scheduled for a kidney transplant
4. Known hypersensitivity or contraindication to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated
5. Synthetic AV dialysis access graft
6. Current or previous history of thrombosis anywhere within the AV dialysis access circuit
7. Evidence of systemic or local infection associated with the AV dialysis access circuit
8. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
9. Stent or stent graft in the AV dialysis access circuit
10. Hemodynamically significant central venous stenosis, unless successfully treated prior to treating the study lesion
11. Presence of occlusion in the AV dialysis access circuit such that a guidewire cannot pass through the lesion
12. Target lesion is greater than or equal to 4 cm in length
13. Reference vessel diameter is greater than 12 mm
14. Presence of more than two distinct lesions (stenoses) in the AV dialysis access circuit

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 5442 0
New Zealand
State/province [1] 5442 0

Funding & Sponsors
Funding source category [1] 288032 0
Commercial sector/Industry
Name [1] 288032 0
Cook Incorporated
Address [1] 288032 0
750 Daniels Way
Bloomington, IN 47404
Country [1] 288032 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cook Incorporated
Address
750 Daniels Way
Bloomington, IN 47404
Country
United States of America
Secondary sponsor category [1] 286749 0
None
Name [1] 286749 0
Address [1] 286749 0
Country [1] 286749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289954 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 289954 0
Ministry of Health
No 1 The Terrace
Wellington
6011
Ethics committee country [1] 289954 0
New Zealand
Date submitted for ethics approval [1] 289954 0
16/09/2013
Approval date [1] 289954 0
15/10/2013
Ethics approval number [1] 289954 0
13/NTA/160

Summary
Brief summary
The purpose of this study is to assess the safety and performance of the Cook Advance Scoring Balloon in treating narrowed blood vessels to improve the effectiveness of haemodialysis treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43106 0
A/Prof Andrew Holden
Address 43106 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 43106 0
New Zealand
Phone 43106 0
+64 (0)9 3074949
Fax 43106 0
Email 43106 0
AndrewH@adhb.govt.nz
Contact person for public queries
Name 43107 0
Miss Helen Knight
Address 43107 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 43107 0
New Zealand
Phone 43107 0
+64 (0)21 405 586
Fax 43107 0
Email 43107 0
HKnight@adhb.govt.nz
Contact person for scientific queries
Name 43108 0
A/Prof Andrew Holden
Address 43108 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 43108 0
New Zealand
Phone 43108 0
+64 (0)9 3074949
Fax 43108 0
Email 43108 0
AndrewH@adhb.govt.nz