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Trial registered on ANZCTR


Registration number
ACTRN12614000504617
Ethics application status
Approved
Date submitted
6/05/2014
Date registered
13/05/2014
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical evaluation of the Thumbwheel Delivery Zilver PTX Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery
Scientific title
Clinical evaluation of the performance and safety of the Zilver PTX stent thumbwheel delivery system in the treatment of symptomatic peripheral arterial disease of the above-the-knee femoropopliteal arteries.
Secondary ID [1] 284469 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 291702 0
Condition category
Condition code
Cardiovascular 292081 292081 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to evaluate a new delivery system for the Zilver PTX (paclitaxel) Drug-Eluting Peripheral Stent. The Zilver PTX Drug-Eluting Peripheral Stent has been approved for use in Australia and New Zealand since 2011. However, this study aims to investigate the performance and safety of a new system (known as a thumbwheel) for delivering the stent to the narrowing in the artery.

The current Zilver PTX Stent has a pin and pull delivery system which requires the doctor to use two hands to pull back the outer covering of the stent, whereas the thumbwheel system only requires the doctor to use one hand. The handle is made to fit comfortably in one hand and a wheel on the top part of the handle is rotated using the thumb. By rotating the wheel the cover is pulled back off the stent and the stent self-expands into the blood vessel. The thumbwheel system is expected to make it easier for the doctor to use.

A single arterial segment within the above-the-knee femoropopliteal artery will be treated per patient; the treated segment will include one de novo or restenosed artherosclerotic lesion with > 50% angiographically-documented diameter stenosis. One or more Zilver PTX stents will be used to treat the study lesion and angiography will be performed during the procedure. The amount of paclitaxel delivered by the stent is 3 micrograms/mm2. Pre- and post-stent dilatation using a standard percutaneous transluminal angioplasty balloon may also be performed. The procedure will take approximately 1-2 hours. A follow-up assessment of symptoms, medications and adverse events will be performed at one month post-procedure.
Intervention code [1] 289224 0
Treatment: Devices
Intervention code [2] 289342 0
Treatment: Drugs
Intervention code [3] 289343 0
Treatment: Surgery
Comparator / control treatment
No comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291953 0
Acute Effectiveness: Absolute mean change in stent length from pre- to post-deployment (less than 10%) measured angiographically.
Timepoint [1] 291953 0
At the time of the procedure.
Primary outcome [2] 291954 0
Placement Accuracy: Determination of semi-quantitative placement accuracy based on a rating scale completed by the investigator.
Timepoint [2] 291954 0
At the time of the procedure.
Primary outcome [3] 291955 0
Acute Safety: Freedom from related death, amputation, and target lesion revascularisation (reintervention).
Timepoint [3] 291955 0
Through 30 days post-procedure.
Secondary outcome [1] 307919 0
Technical Success: Composite of optimal or acceptable placement accuracy and less than 10% stent length change upon deployment.
Timepoint [1] 307919 0
At the time of the procedure.

Eligibility
Key inclusion criteria
A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:

1. One atherosclerotic lesion of the above-the-knee femoropopliteal artery with >50% angiographically-documented stenosis
2. Reference vessel diameter of 4-7 mm
3. Symptomatic for peripheral arterial disease classified as Rutherford Category 2-4
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded from enrollment into the study if any of the following are true:

General Exclusion Criteria
1. Unable or unwilling to sign and date informed consent
2. Less than 18 years of age
3. Unable or unwilling to comply with follow-up schedule
4. Simultaneous participation in another investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
5. Pregnant, breastfeeding or planning to become pregnant in the next 5 years.
6. Medical condition or disorder that would limit life expectancy < 30 days
7. Prior stent in the study vessel
8. Underwent any surgical or interventional procedure within 30 days prior to the study procedure.
9. Planned surgical or interventional procedure within 30 days after the study procedure.
10. Contraindication to antiplatelet or anticoagulant medications
11. Known hypersensitivity or contraindication to study products (note: study products not limited to device materials, contrast, and antiplatelet or anticoagulant medications).
12. Unresolved systemic or local infection which could affect the clinical study outcomes.
13. Significant stenosis (>50%) or occlusion of inflow tract (proximal ipsilateral iliofemoral or aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis).
14. Lacks at least one patent runoff vessel with < 50% stenosis; if runoff vessel is treated prior to the procedure the treatment must be successful with < 30% residual stenosis.
15. Untreated angiographically-evident thrombus in the target lesion.
16. Lesion requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery.

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
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 in Australia
Recruitment state(s)
Recruitment hospital [1] 3134 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 3135 0
Frankston Hospital - Frankston
Recruitment outside Australia
Country [1] 6017 0
New Zealand
State/province [1] 6017 0
Country [2] 6466 0
Germany
State/province [2] 6466 0

Funding & Sponsors
Funding source category [1] 289118 0
Commercial sector/Industry
Name [1] 289118 0
Cook Incorporated
Address [1] 289118 0
750 Daniels Way
Bloomington, IN 47402
Country [1] 289118 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cook Incorporated
Address
750 Daniels Way
Bloomington, IN 47402
Country
United States of America
Secondary sponsor category [1] 287780 0
None
Name [1] 287780 0
Address [1] 287780 0
Country [1] 287780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290902 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 290902 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 290902 0
New Zealand
Date submitted for ethics approval [1] 290902 0
Approval date [1] 290902 0
15/04/2014
Ethics approval number [1] 290902 0
14/NTA/50

Summary
Brief summary
The purpose of this study is to evaluate the performance and safety of a new delivery system for the Zilver PTX Drug-Eluting Peripheral Stent in the treatment of peripheral arterial disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47874 0
A/Prof Andrew Holden
Address 47874 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 47874 0
New Zealand
Phone 47874 0
+64 (0)9 3074949
Fax 47874 0
Email 47874 0
AndrewH@adhb.govt.nz
Contact person for public queries
Name 47875 0
Ms Donna Katae
Address 47875 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 47875 0
New Zealand
Phone 47875 0
+64 (0)9 3074949
Fax 47875 0
Email 47875 0
DKatae@adhb.govt.nz
Contact person for scientific queries
Name 47876 0
A/Prof Andrew Holden
Address 47876 0
Radiology Department
Auckland City Hospital
Park Road
Grafton 1142
Auckland
Country 47876 0
New Zealand
Phone 47876 0
+64 (0)9 3074949
Fax 47876 0
Email 47876 0
AndrewH@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary