Back to resultsVISIBILITY™ Iliac Study
Primary Purpose
Peripheral Arterial Disease, Claudication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visi-Pro™ Balloon Expandable Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, claudication, stent, VISI-Pro, Iliac artery
Eligibility Criteria
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
Sites / Locations
- Holy Name Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Visi-Pro™ Balloon Expandable Stent System
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01402700
Brief Title
VISIBILITY™ Iliac Study
Official Title
Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Claudication
Keywords
Peripheral arterial disease, claudication, stent, VISI-Pro, Iliac artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visi-Pro™ Balloon Expandable Stent System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Visi-Pro™ Balloon Expandable Stent System
Intervention Description
Implantation of one or more study devices in the common and/or external iliac artery.
Primary Outcome Measure Information:
Title
Major Adverse Event Rate at 9 Months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L. Faries, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John H. Rundback, M.D.
Organizational Affiliation
Holy Name Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28351204
Citation
Rundback JH, Peeters P, George JC, Jaff MR, Faries PL. Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months. J Endovasc Ther. 2017 Jun;24(3):342-348. doi: 10.1177/1526602817692960. Epub 2017 Feb 1.
Results Reference
derived
Learn more about this trial
VISIBILITY™ Iliac Study
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