Feasibility Cohort Presented for VIRTUS Iliofemoral Venous Stenting Study

September 19, 2016—Stephen Black, MD, presented results from the VIRTUS trial during the first Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

VIRTUS is being conducted under an investigational device exemption from the US Food and Drug Administration to assess the safety and efficacy of the Vici venous stent system (Veniti, Inc.) in achieving patency of the target venous lesion in patients with clinically significant, chronic, nonmalignant occlusion of the iliofemoral venous tract. The prospective, multicenter, single-arm, nonrandomized global trial is enrolling a total of 200 patients at clinical centers worldwide, including 30 feasibility patients and 170 pivotal patients.

In the VIVA 16 presentation, Dr. Black advised that inclusion criteria of the study are symptomatic patients who are assessed by venography and intravascular ultrasound (IVUS) and who are ≥ 18 years of age. Exclusion criteria are patients whose vein diameters are not within limits stated in the current Vici venous stent instructions for use and also those who have had any previous surgical or endovascular procedures on the target vessel.

The follow-up intervals are 30 days, 6 months, 12 months, and yearly thereafter up to 5 years after the index procedure. Baseline assessments include, but are not limited to, medical history, laboratory testing, chronic venous insufficiency questionnaire, venous clinical severity score, venography, and IVUS.

The background of the study is that although venography has a long history in the diagnosis of venous disease, data suggest that IVUS may be a better tool to define lesion severity.

Dr. Black reported that in the VIRTUS feasibility cohort, preprocedure venography and IVUS measurements of minimum luminal diameter were highly correlated. Postprocedure percentage stenosis was not highly correlated between venography and IVUS. The degree of stent oversizing was greater by venography than IVUS. Venography is important for guiding appropriate stent deployment, although IVUS may be more accurate for assessing the severity of a lesion and for proper venous stent sizing.

VIRTUS patients will continue to be followed, and more data will be analyzed and presented as they become available, advised Dr. Black at VIVA 16.