N/A
Completed N=45
Zilver PTX Drug-Eluting Peripheral Stent Study
Source: ClinicalTrials.gov NCT01348425 ↗Enrolled (actual)
45
Serious AEs
11.1%
Results posted
Apr 2014
Primary outcomePrimary: Percent Change in Stent Length Upon Deployment — 0.5; -0.2 Change in stent length (%) — p=<0.01
Summary
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Stent Length Upon Deployment |
0.5; -0.2 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
- Reference vessel diameter of 4 - 9 mm
- Rutherford category ≥ 2
- Resting ankle brachial index 50%) or occlusion of inflow tract not successfully treated before the study procedure
- Lacks at least one patent runoff vessel
- Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
Data sourced from ClinicalTrials.gov (NCT01348425). 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.