N/A
Completed N=34
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
Peripheral Arterial Diseases
Source: ClinicalTrials.gov NCT02066740 ↗
Enrolled (actual)
34
Serious AEs
11.8%
Results posted
Sep 2015
Primary outcomePrimary: Absence of Stent Elongation — 95.6 percentage absence of stent elongation
Summary
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Stent Elongation |
95.6 | — |
| PRIMARY Successful Stent Deployment |
100.0 | — |
Eligibility Criteria
Inclusion Criteria
- Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
- or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.
Exclusion Criteria
- Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
Data sourced from ClinicalTrials.gov (NCT02066740). 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.