DURABILITY™ Iliac Study

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.

Completed

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.

Device

Implantation of one or more study devices in the common and/or external iliac artery.

Primary outcomes

Major Adverse Event Rate

Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2016
First posted: Jul 25, 2011
Registry last updated: Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed