Zilver PTX Delivery System
Not Applicable
Completed
- Conditions
- Peripheral Vascular Disease
- Interventions
- Device: Zilver® PTX® Drug-Eluting Peripheral Stent
- Registration Number
- NCT02271529
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug Eluting Stent Zilver® PTX® Drug-Eluting Peripheral Stent Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent
- Primary Outcome Measures
Name Time Method Mean Percent Change in Stent Length Upon Deployment Immediately following completion of the stent placement procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Frankston Hospital
🇦🇺Frankston, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
🇩🇪Bad Krozingen, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand