DURABILITY™ Iliac Study

Medtronic

Status: Completed

Conditions: Claudication; Peripheral Arterial Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01400919

P-5684

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems

Experimental group

Description:

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.

Treatment:

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