NCT02574481

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535 subjects will be enrolled at up to 75 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, non-randomized, Long Lesion substudy.

Conditions

• Atherosclerosis of Native Arteries of the Extremities

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-28
• Completion: 2022-04-12
• First posted: 2015-10-14
• Last updated: 2023-05-08
• Results posted: 2019-01-07

Locations

68 sites across 7 countries: United States, Austria, Belgium, Canada, Germany, Japan, New Zealand

Regulatory

• FDA-regulated device study