ELUVIA™
Drug-Eluting Vascular Stent System
Objective
Trial Design
- Eligible patients with chronic, symptomatic (Rutherford categories 2, 3 or 4) lower limb ischemia and stenotic, restenotic or occlusive lesions in the native superficial femoral artery or proximal popliteal artery (n=57)
- Degree of stenosis ≥ 70% (visual angiographic assessment)
- Vessel diameter ≥ 4 and ≤ 6mm
- Total lesion length ≥ 30 mm and ≤ 110 mm
Baseline Characteristics
| Patient Demographics | n = 57 subjects | Lesion Characteristics (Core Lab) |
n = 57 lesions |
|---|---|---|---|
| Age (Years) | 69.3 ± 9.3 | Reference Vessel Diameter | 5.2 ± 0.8 |
| Male Gender | 82.5% | Target Lesion Length | 70.8 ± 28.1 |
| Diabetes Mellitus | 35.1% | Severely Calcified | 64.9% |
| History of Smoking | 87.7% | Percent Diameter Stenosis | 86.3% ± 16.2% |
| Hypertension | 73.7% | Total Occlusions | 46.2% |
| Hyperlipidemia | 63.2% | % Extending into Distal SFA | 77.2% |
| Coronary Artery Disease | 38.6% | % Extending into PPA | 8.8% |
2-year Results
The Eluvia Drug-Eluting Stent System continues to demonstrate unprecedented clinical outcomes with a 92.5% freedom from TLR at 2 years, the highest reported in comparable SFA clinical trials.
Safety Results
- 7.5% composite major adverse event rate at 2 years
- 4 TLR events (4/53)
Stent Integrity
- No stent fractures at 2 years upon angiographic core lab analysis
Patient Outcomes
- 91% of patients presented with no or minimal claudication at 2 years
- 91% of patients sustained clinical improvement through 2 years
- ABI improvement sustained through 2 years (0.94±0.22)
Sustained drug release for sustained clinical outcomes
