IMPERIAL Long Lesion Sub-Study

Objective

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.

 

Trial Design

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.

 

Baseline Characteristics

Patient Demographics
Lesion Characteristics
 
IMPERIAL Long Lesion Sub-Study Kaplan-Meier Primary Patency Rate: 12-Month Results

 

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


6.5% TLR Rate  in 162.8mm Lesions

Patient Outcomes

  • 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
Rutherford Category
 
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