Status:
COMPLETED
Zilver PTX Delivery System
Lead Sponsor:
Cook Group Incorporated
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
Eligibility Criteria
Inclusion
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
- Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02271529
Start Date
September 1 2014
End Date
May 1 2015
Last Update
February 26 2016
Active Locations (6)
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1
Frankston Hospital
Frankston, Australia, Vic 3199
2
Princess Alexandra Hospital
Woolloongabba, Australia, Qld 4102
3
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, Germany, D-79189
4
Auckland City Hospital
Auckland, New Zealand, 1023