CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
EverFlex™ Self-Expanding Peripheral Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680835
NCT01680835N/ACompleted
CompareCT.gov

The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study

Medtronic Endovascular·interventional·Posted Sep 7, 2012·Updated Dec 26, 2019

In Brief

A clinical study evaluating EverFlex™ Self-Expanding Peripheral Stent System for Peripheral Arterial Disease and Lower Extremity Arterial Disease. Completed, enrolled 108 participants across 23 sites.

Detailed Summary

This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Lower Extremity Arterial Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartJan 14, 2013
Primary CompletionOct 23, 2018
Study CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.8 years ago

Interventions

EverFlex™ Self-Expanding Peripheral Stent Systemdevice

Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.