N/A
N=75
VISIBILITY™ Iliac Study
Peripheral Arterial Disease · Claudication
Bottom Line
View on ClinicalTrials.gov: NCT01402700 ↗Enrolled (actual)
75
Serious AEs
50.7%
Results posted
Sep 2015
Primary outcome: Primary: Major Adverse Event Rate at 9 Months — 4.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Visi-Pro™ Balloon Expandable Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Event Rate at 9 Months |
4.0 | — |
Summary
The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Eligibility Criteria
Inclusion Criteria
- Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
- Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
- Willing to comply with all follow-up evaluations at the specified times.
- Provides written informed consent prior to enrollment in the study.
Exclusion Criteria
- Previous implantation of stent(s) in the target vessel.
- Received endovascular treatment of the target lesion within six months prior to the index procedure.
- Known hypersensitivity to contrast material that cannot be adequately pretreated.
- Known hypersensitivity to 316L stainless Steel.
- Life expectancy of less than 12 months
Data sourced from ClinicalTrials.gov (NCT01402700). 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.