VICI Venous Stent™
Assess safety & effectiveness in achieving patency of target venous lesion through 12 months post stent placement, in patients with obstruction of the iliofemoral venous outflow tract.
VIRTUS Trial Design
Prospective, multi-center (22 sites in the US and Europe)single arm, non-randomized.
Key Inclusion Criteria
Unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof
- ≥50% reduction in target vessel lumen diameter (venogram)
Clinically significant venous obstruction defined as:CEAP “C” ≥3 OR VCSS Pain ≥2
Primary patency rate at 12 months post-intervention
- Freedom from occlusion by thrombosis
- Freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency
- Freedom from in-stent stenosis more than 50% by venogram
Primary endpoint was met2
Primary patency rate exceeded the performance goal of 72.1% (p<0.0001)3,4
VIRTUS Clinical Trial | 12-month results
98.8% freedom from MAEs through 30 days
Primary endpoint was met2:
Safety rate exceeded the performance goal of 94%5
- VIRTUS demonstrated a clinically meaningful 4.4 decrease in the VCSS score from baseline out to12 months.
- Vici shifted patients with a severe VCSS score from almost 66% down to 27%,and increased the patients in the mild VCSS score 4-fold.
VIRTUS Clinical Trial Conclusion
VIRTUS primary safety and effectiveness endpoints successfully met:
- 84% 12-month primary patency
- 98.8% freedom from MAE through 30 days
Patient sample with challenging characteristics:
- 75% of patients with chronic PTS
- 25% of patients with CEAP Clinical Severity C5 and C6
- 31% with total occlusions
- 32% had involvement of the entire iliofemoral segment