Completed
DURABILITY IIThe US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
What is being tested
PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Device
Who is being recruted
Cardiovascular Diseases+4
+ Intermittent Claudication
+ Signs and Symptoms
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: August 2007
Summary
Principal SponsorMedtronic Endovascular
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2007
Actual date on which the first participant was enrolled.This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.
Official TitleThe US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II
Principal SponsorMedtronic Endovascular
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
287 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesIntermittent ClaudicationSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesPeripheral Vascular DiseasesPeripheral Arterial Disease
Criteria
4 inclusion criteria required to participate
Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
Symptomatic femoral-popliteal atherosclerosis.
Willing to comply with all follow-up evaluations at the specified times.
Provides written informed consent prior to enrollment in the study.
5 exclusion criteria prevent from participating
Previously implanted stent(s) or stent graft(s) in the target vessel.
Planned use of devices other than angioplasty balloons during procedure.
Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
Life expectancy of less than 12 months.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalQualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers