At a glance
ClinicalIndex Comparison RecordN/ACompleted· 287 enrolled
Drug / intervention
PROTÉGÉ® EverFlex™ Self-Expanding 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.
The 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
In Brief
A clinical study evaluating PROTÉGÉ® EverFlex™ Self-Expanding Stent System for Peripheral Vascular Diseases and Claudication. Completed, enrolled 287 participants.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Diseases, Claudication
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedSep 2007
Primary CompletionMar 2012
Study CompletionJul 2013
TodayJul 2026
First PostedSep 17, 2007
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.8 years ago
Interventions
PROTÉGÉ® EverFlex™ Self-Expanding Stent Systemdevice
Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.