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Clinical trial

ELUVIA� Drug-eluting Stent Versus Zilver� PTX� Stent (IMPERIAL)

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Last updated:1st Dec 2015

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.

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Estimated Enrollment: 485
Study Start Date: December 2015
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

- Experimental:
ELUVIA Stent Implantation
- Active Comparator: Zilver PTX Stent Implantation

Category Value
Study start date 2015-12-01

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