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DURABILITY™ Iliac Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01400919
First received: July 21, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

July 21, 2011
May 9, 2013
July 2011
February 2014   (final data collection date for primary outcome measure)
Major Adverse Event Rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01400919 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
DURABILITY™ Iliac Study
Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Claudication
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.
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.
Intervention: Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
January 2016
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01400919
P-5684
Not Provided
Covidien
Covidien
Not Provided
Principal Investigator: Peter L. Faries, M.D. Mount Sinai School of Medicine
Principal Investigator: John H. Rundback, M.D. Holy Name Medical Center
Covidien
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP