N/A
Completed N=40
Zilver PTX Delivery System
Source: ClinicalTrials.gov NCT02271529 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Feb 2016
Primary outcomePrimary: Mean Percent Change in Stent Length Upon Deployment — -1.0 percentage of change in stent length — p=<0.01
Summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Stent Length Upon Deployment |
-1.0 | <0.01 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02271529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.