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NCT01400919 Clinical Trial

DURABILITY™ Iliac Study

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01400919
Other study ID # P-5684
Secondary ID
Status Completed
Phase N/A
First received July 21, 2011
Last updated February 5, 2018
Start date July 2011
Est. completion date January 2016

Study information
Verified date February 2018
Source Medtronic Endovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date January 2016
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Event Rate 9 months
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