To evaluate the safety and effectiveness of the Eluvia Drug-Eluting Vascular Stent System for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
A 50 subject concurrent, non-blinded, non-randomized, single arm (Eluvia) long lesion sub-study.
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
Primary Safety Endpoints: The primary safety endpoint assesses the 12-month MAE-free rate.
Primary Effectiveness Endpoint: The primary effectiveness endpoint assesses the 12-month.
12-Month Primary Patency Results
Eluvia demonstrated 87.9% primary patency
in the IMPERIAL Long Lesion Sub-Study.
12-Month Safety Results
- 93.5% of patients were free of Major Adverse Events at 12 months
- 87.2% of Eluvia patients presented with no or minimal claudication (Rutherford 0-1) at 12 months
- 91.5% of Eluvia patients had improvement by at least 1 Rutherford category compared with baseline without the need for TLR
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