VISIBILITY™ Iliac Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Claudication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Visi-Pro™ Balloon Expandable Stent System

The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.

Group Type EXPERIMENTAL

Visi-Pro™ Balloon Expandable Stent System

Intervention Type DEVICE

Implantation of one or more study devices in the common and/or external iliac artery.

Interventions

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Visi-Pro™ Balloon Expandable Stent System

Implantation of one or more study devices in the common and/or external iliac artery.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No