Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02271529