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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02271529




Registration number
NCT02271529
Ethics application status
Date submitted
17/10/2014
Date registered
22/10/2014
Date last updated
26/02/2016

Titles & IDs
Public title
Zilver PTX Delivery System
Scientific title
Zilver Paclitaxel(PTX) Thumbwheel Delivery System
Secondary ID [1] 0 0
13-14
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Zilver® PTX® Drug-Eluting Peripheral Stent

Experimental: Drug Eluting Stent - Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent


Treatment: Devices: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Percent Change in Stent Length Upon Deployment
Timepoint [1] 0 0
Immediately following completion of the stent placement procedure

Eligibility
Key inclusion criteria
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal
arteries

- Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is < 18 years of age

- Patient unable to complete required follow-up assessments

- Patient unwilling to sign and date the informed consent

- Simultaneous participation in another investigational drug or device study

- Pregnant, breastfeeding or planning to become pregnant in the next 5 years

- Additional medical/anatomical restrictions as specified in the Clinical Investigation
Plan

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Frankston Hospital - Frankston
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
Vic 3199 - Frankston
Recruitment postcode(s) [2] 0 0
Qld 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bad Krozingen
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cook Group Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel
delivery system.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02271529
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland District Health Board
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02271529