N/A
Completed N=200
Zilver® PTX® V Clinical Study
Source: ClinicalTrials.gov NCT01901289 ↗Enrolled (actual)
200
Serious AEs
77.0%
Results posted
Jul 2018
Primary outcomePrimary: Patients Without Target Lesion Revascularization (TLR) — 186 Participants
Summary
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Without Target Lesion Revascularization (TLR) |
186 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has signed and dated the informed consent.
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
- Patient agrees to return for the required follow-up assessments.
Exclusion Criteria
- Patient is < 18 years of age.
- Patient has significant stenosis of inflow tract not successfully treated before this procedure.
- Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
Data sourced from ClinicalTrials.gov (NCT01901289). 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.