VIRTUS Clinical Trial | 12-Month Data1

Pivotal Cohort 12-Month Primary Safety and Efficacy Results of the VICI Venous Stent System.

Objective

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.

 

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

Definition:

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 12-Month Primary Patency Rate chart
VICI Venous Stent System Etiology

VIRTUS Clinical Trial | 12-Month Results

 

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.
  • 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.
VCSS charts
 

VIRTUS Clinical Trial | Conclusions

 

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

VIRTUS Challenging Patient Characteristics

 

 

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VICI Venous Stent System Abbreviated Statement ›
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