VICI Venous Stent™

System

VIRTUS Clinical Trial

VIRTUS Clinical Trial Video

The VICI Venous Stent System is a self-expanding nitinol stent specifically designed to meet the challenges of venous anatomy.

Caution: Vici is an investigational device. Limited by US law to investigational use only. Not available for sale.

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.

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

Baseline Characteristics

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 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 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

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