Zilver PTX Delivery System
Zilver Paclitaxel(PTX) Thumbwheel Delivery System
1 other identifier
interventional
40
3 countries
6
Brief Summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
February 26, 2016
CompletedFebruary 26, 2016
January 1, 2016
8 months
October 17, 2014
January 29, 2016
January 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent Change in Stent Length Upon Deployment
Immediately following completion of the stent placement procedure
Study Arms (1)
Drug Eluting Stent
EXPERIMENTALZilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent
Interventions
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Eligibility Criteria
You may qualify if:
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
- Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Frankston Hospital
Frankston, Vic 3199, Australia
Princess Alexandra Hospital
Woolloongabba, Qld 4102, Australia
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, D-79189, Germany
Auckland City Hospital
Auckland, 1023, New Zealand
Waikato Hospital
Hamilton, 3248, New Zealand
Wellington Hospital
Wellington, 3248, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, Director, Clinical Affairs
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Holden, MD
Auckland District Health Board
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 22, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
February 26, 2016
Results First Posted
February 26, 2016
Record last verified: 2016-01