NCT02921230

Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery

A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 775 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

Detailed description

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4. The study is a 2:1 randomized (ELUVIA vs Self-Expanding Bare Nitinol Stents), controlled, single-blind, superiority trial (RCT). The objective of the study is to evaluate the effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 210 mm in length when compared against bare metal stents, and collect additional data including health economics data.

Conditions

• Arterial Occlusive Diseases
• Atherosclerosis
• Vascular Diseases
• Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	Peripheral stenting	stent implantation during the index procedure

Timeline

• Start date: 2016-10-25
• Primary completion: 2021-07-02
• Completion: 2023-11-06
• First posted: 2016-10-03
• Last updated: 2025-02-24
• Results posted: 2024-10-28

Locations

60 sites across 10 countries: Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom