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ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

NCT02574481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2023-05-08

Study results available
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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.

Conditions

  • Atherosclerosis of Native Arteries of the Extremities

Interventions

DEVICE

ELUVIA (Stent Implantation)

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

DEVICE

Zilver PTX (Stent Implantation)

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • William Gray, MD · Main Line Health

  • Stefan Müller-Hülsbeck, Prof · Ev. Luth. Diakonissenanstalt Flensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-28
Completion
2022-04-12
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Germany
  • Japan
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574481 on ClinicalTrials.gov