US-based Cook Medical has initiated a prospective, non-randomized clinical research study of its Zilver Vena Venous Self-Expanding Stent.
The VIVO study, which will enroll 243 adult patients aged 18 years and older across 30 participating sites in the US and the Asia-Pacific region, will evaluate the safety and effectiveness of the stent in patients with symptomatic iliofemoral venous outflow obstruction.
Such patients are also characterized by leg pain, throbbing, swelling and skin discoloration in the legs.
Jobst Vascular Institute director Anthony Comerota said, "This is an important trial which is intended to objectively assess the endovenous correction of symptomatic iliofemoral vein stenosis with a stent designed for this specific purpose."
The primary study results will be evaluated in one year after stent placement, followed by patient follow-up through three years, claims the company.
The Zilver stent is an investigational device and is not approved for sale in the US.
