VISIBILITY™ Iliac Study

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Claudication
• Interventions: Device: Visi-Pro™ Balloon Expandable Stent System

• Registration Number: NCT01402700
• Lead Sponsor: Medtronic Endovascular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Primary Completion: 2013-07
• Results First Submitted: 2015-08-11
• Results First Submitted QC: 2015-08-14
• Study Completion: 2015-09
• Results First Posted: 2015-09-16
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visi-Pro™ Balloon Expandable Stent System	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.

Primary Outcome Measures

Name	Time	Method
Major Adverse Event Rate at 9 Months	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.

Trial Locations

Locations (1)

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States