Global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication.
- 465 (RCT) patients across 64 sites
- 5-year follow-up
- Primary patency, freedom from TLR, ankle-brachial index (ABI), Rutherford classification and stent fracture rate evaluated
- Safety: Major Adverse Events defined as all causes of death through 1 month, Target Limb Major Amputation through 12 months and/or Target Lesion Revascularization (TLR) through 12 months.
- Efficacy: Assess primary vessel patency* at 12 months post-procedure.
Key Eligibility Criteria
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA.
- Degree of stenosis ≥ 70% by visual angiographic assessment.
- Vessel diameter ≥ 4 and ≤ 6 mm
- Total lesion length ≥ 30 mm and ≤ 140 mm