3:27 PM Abstract No. 354 Update on the Cook VIVO clinical study: a multicenter evaluation of the Zilver vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction

Abstract

The purpose of this prospective, global, single-arm, investigational study is to evaluate the safety and effectiveness of the Zilver Vena Venous Stent in the treatment of patients with symptomatic iliofemoral venous outflow obstruction. Symptomatic patients with venous outflow obstruction in a single iliofemoral venous segment underwent treatment with the Zilver Vena Venous Stent (Cook Medical, Limerick, Ireland). The primary study endpoints are: 30-day primary safety endpoint (freedom from major adverse events) and 12-month primary effectiveness endpoint (primary quantitative patency). 243 patients (70% female; 82% white; mean age of 53 ± 15 years) were enrolled at 30 institutions; study enrollment is complete and patient follow-up is ongoing with data collection out to 36 months. The site-reported indications for stent placement included (note: a single patient may have multiple indications): iliac vein compression by the iliac artery (n = 190; 78%), stenosis due to chronic post-thrombotic obstruction (n = 71; 29%), stenosis after treatment for acute deep vein thrombosis (n = 37; 15%), iatrogenic stenosis (n = 2; 0.8%), extrinsic compression from a mass (n = 2; 0.8%), or other indications (n = 12; 5%). Based on site-reported data, most lesions (n = 209; 86%) affected the vein(s) of the left iliofemoral venous outflow tract. The treated vessel segments included: common iliac vein (n = 216), external iliac vein (n = 148), common femoral vein (n = 66), and femoral vein (n = 7). Enrollment in the VIVO Study is complete, with clinical and imaging follow-up data collection ongoing. An updated study status will be presented, including final baseline patient and lesion characteristics and procedural outcomes.