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
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Claudication
Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Major Adverse Event Rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: July 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400919

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Peter L. Faries, M.D. Mount Sinai School of Medicine
Principal Investigator: John H. Rundback, M.D. Holy Name Medical Center
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01400919     History of Changes
Other Study ID Numbers: P-5684
Study First Received: July 21, 2011
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014