Back to resultsDURABILITY™ Iliac Study
Primary Purpose
Peripheral Arterial Disease, Claudication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding 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, EverFlex, GPS, 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 nickel-titanium.
- Life expectancy of less than 12 months
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Arm Description
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Outcomes
Primary Outcome Measures
Major Adverse Event Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01400919
Brief Title
DURABILITY™ Iliac Study
Official Title
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ 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
November 2013 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
5. Study Description
Brief Summary
The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.
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, EverFlex, GPS, 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
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Arm Type
Experimental
Arm Description
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Intervention Type
Device
Intervention Name(s)
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding 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
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 nickel-titanium.
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
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
DURABILITY™ Iliac Study
We'll reach out to this number within 24 hrs