VISIBILITY™ Iliac Study

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease, Claudication

In brief

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.

Key facts

Study ID

NCT01402700

Run by

Medtronic Endovascular

People needed

75

Starts

2011-07-01

Expected to finish

2015-09-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Holy Name Medical Center — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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