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
• 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
• 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

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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