VISIBILITY™ Iliac Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holy Name Medical Center

Teaneck, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visi-Pro™ Balloon Expandable Stent System

Device

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

Primary outcomes

Major Adverse Event Rate at 9 Months

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2015
First posted: Jul 26, 2011
Registry last updated: Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed