Objective

Assess safety & effectiveness in achieving patency of target venous lesion  post stent placement, in patients with obstruction of the iliofemoral venous outflow tract.

 

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

Baseline Characteristics

VIRTUS Baseline Characteristics - Patient Demographics
VIRTUS Baseline Characteristics - Clinical Assessment
 

VIRTUS Clinical Trial | Efficacy Results

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

24-Month Results Pivotal Cohort (N = 170)

  • 79.4% primary patency at 24 months (DUS)
  • 74% of evaluable DUS from post-thrombotic etiology, consistent with overall enrollment
VIRTUS 12-Month and 24-Month Primary Patency Rate chart
VICI Venous Stent System Etiology

VIRTUS Clinical Trial

12-Month Results

Safety Results:

98.8% freedom from MAEs through 30 days

Primary endpoint was met2:

Safety rate exceeded the performance goal of 94%5

Patient Outcomes

  • VIRTUS demonstrated a clinically meaningful 4.4 decrease in the VCSS score from baseline out to 12 months.
  • 84% of patients experienced VCSS improvement.
VCSS charts
 
 

VIRTUS Clinical Trial | Conclusions

 

VIRTUS primary safety and effectiveness endpoints successfully met:

84% 12-month primary patency

 

 

Patient sample with challenging characteristics

VIRTUS Challenging Patient Characteristics

 

 

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VICI Venous Stent System Abbreviated Statement ›
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