DURABILITY™ Iliac Study
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedResults Posted
Study results publicly available
June 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMarch 7, 2018
February 1, 2018
2.3 years
July 21, 2011
June 8, 2015
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Event Rate
9 months
Study Arms (1)
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
EXPERIMENTALThe 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.
Interventions
Implantation of one or more study devices in the common and/or external iliac artery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai School of Medicine
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Cihlar
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Peter L. Faries, M.D.
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
John H. Rundback, M.D.
Holy Name Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 25, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2013
Study Completion
January 1, 2016
Last Updated
March 7, 2018
Results First Posted
June 24, 2015
Record last verified: 2018-02