DURABILITY™ Iliac Study

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease, Claudication

In brief

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.

Key facts

Study ID

NCT01400919

Run by

Medtronic Endovascular

People needed

75

Starts

2011-07-01

Expected to finish

2016-01-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.