VISIBILITY™ Iliac Study

Medtronic Endovascular75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Claudication

Interventions

Visi-Pro™ Balloon Expandable Stent SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Holy Name Medical Center

Teaneck, New Jersey, United States

Outcomes

Primary Outcomes

Major Adverse Event Rate at 9 Months

The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.

Time frame: 9 months

Data from ClinicalTrials.gov

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