DURABILITY™ Iliac Study

Medtronic Endovascular75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Claudication

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Major Adverse Event Rate

Time frame: 9 months

Data from ClinicalTrials.gov

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