CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 524 enrolled
Drug / intervention
ELUVIA (Stent Implantation) +1 moredevice
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/NCT02574481
NCT02574481N/ACompleted

A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

Boston Scientific Corporation·interventional·Posted Oct 14, 2015·Updated May 8, 2023

In Brief

A clinical study evaluating ELUVIA (Stent Implantation) and Zilver PTX (Stent Implantation) for Atherosclerosis of Native Arteries of the Extremities. Completed, enrolled 524 participants across 68 sites in 7 countries.

Detailed Summary

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, Germany, Japan, New Zealand, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 14, 2015
Enrollment StartDec 1, 2015
Primary CompletionDec 28, 2017
Study CompletionApr 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.7 years ago

Interventions

ELUVIA (Stent Implantation)device

Drug-eluting self-expanding stent implantation during the index procedure.

Zilver PTX (Stent Implantation)device

Drug-eluting self-expanding stent implantation during the index procedure.