Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 750
Summary
- Conditions
- Arterial Occlusive Diseases
- Arteriosclerosis
- Atherosclerosis
- Vascular Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The EMINENT study is a prospective, multi-center study confirming the superior 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 ...
The EMINENT study is a prospective, multi-center study confirming the superior 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 confirm the superior 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.
Tracking Information
- NCT #
- NCT02921230
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Giovanni Torsello, MD Sint-Franziskus-Hospital GmbH Principal Investigator: Yann Goueffic Hôpital St Joseph Paris
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