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DURABILITY™ Iliac Study

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ClinicalTrials.gov Identifier: NCT01400919
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : June 24, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Claudication Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
Study Start Date : July 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
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.
Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Implantation of one or more study devices in the common and/or external iliac artery.




Primary Outcome Measures :
  1. Major Adverse Event Rate [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400919


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01400919     History of Changes
Other Study ID Numbers: P-5684
First Posted: July 25, 2011    Key Record Dates
Results First Posted: June 24, 2015
Last Update Posted: March 7, 2018
Last Verified: February 2018

Keywords provided by Medtronic Endovascular:
Peripheral arterial disease
claudication
stent
EverFlex
GPS
Iliac Artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents