ABRE IDE Study of Medtronic’s Venous Stent Finishes Enrollment, Baseline Demographics Released

Hollywood, FL (January 24, 2020) -- Enrollment is completed and baseline demographics available for the ABRE IDE study of the ABRE Venous Stent (Medtronic), according to principal instigator Erin Murphy, MD, director of the venous and lymphatic program at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, North Carolina. 

ABRE is a prospective safety and efficacy study and will test the ABRE self-expanding venous stent and delivery system for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease. The ABRE stent is an over-the-wire nitinol-titanium alloy stent that comes in diameters of 10-20 mm and stent lengths between 40 and 150 mm.

Two hundred patients (128 in the U.S. and 72 in the European Union) were enrolled at 24 clinical sites in less than 12 months. Mean age of the study cohort is 51.5 years and 66.5% are female. The majority (78.5%) are white and mean BMI is 29.5.

Importantly, said Dr. Murphy, the study includes all primary patient disease categories that cause occlusive disease: post-thrombotic syndrome in 47.5%, non-thrombotic iliac vein lesion in 36.0%, and acute deep vein thrombosis (DVT) in 16.5%.

“About one-third had venous claudication, just under one-quarter had a family history of DVT, thrombophilia in 11% and a cancer diagnosis in 11%, and [an IVC] filter was present in 5%, matching our incidence of prior DVT history,” reported Murphy.

Patients will be followed for 36 months. Twelve-month follow-up is completed and a data release is expected in the spring of this year.