The study demonstrated favourable outcomes for Medtronic’s self-expanding venous stent in patients with venous outflow obstruction
Medtronic has unveiled results from the ABRE clinical study to evaluate the investigational Abre venous self-expanding stent system in treating iliofemoral venous outflow obstruction.
The global medical technology firm said that study has met the primary safety and effectiveness endpoints.
Venous outflow obstruction, or deep venous obstruction is said to occur when veins in the deep venous system become compressed and restrict blood flow, resulting in pain and discomfort, and also limits patient’s mobility, and impairing quality of life.
ABRE Study European principal investigator Stephen Black said: “Deep venous lesions are uniquely challenging and require a stent that is strong, flexible, and durable, while also being able to maintain blood flow.
“It is encouraging that the study was able to meet its primary endpoints and demonstrated strong results with secondary endpoints. This is especially remarkable in this challenging study population with stents extending below the inguinal ligament in nearly half of enrolled subjects.”
ABRE Study is an interventional, single-arm, multi-centre clinical trial evaluating 200 subjects
The ABRE Study is an interventional, single-arm, multi-centre study in 200 subjects with symptomatic iliofemoral venous outflow obstruction, and has reached the primary safety and effectiveness endpoints.
The primary effectiveness endpoint evaluated primary patency at 12 months, and the primary safety endpoint evaluated the incidence of composite Major Adverse Events (MAE) within 30 days after stenting an obstruction in the iliofemoral venous segment.
The study enrolled subjects across the spectrum of deep venous disease, including those with post-thrombotic syndrome (PTS), non-thrombotic iliac vein lesions (NIVL), and those who presented with an acute deep vein thrombosis (aDVT).
The clinical study has reached its primary safety endpoint with 2% rate of major adverse events (MAEs) and has also met its primary effectiveness endpoint with 88% overall primary patency rate.
The significant secondary endpoints results from the study include device success during the index procedure, no stent fractures and delayed stent migration, sustained improvement in quality of life measures and venous functional assessment scores.
Medtronic aortic, peripheral, and venous medical affairs, education and clinical research vice president Simona Zannetti said: “Our goal with the ABRE study is to generate evidence supporting the performance of the Abre stent in patients with broad indications for iliofemoral venous obstruction.
“This includes patients with an initial presentation of acute deep vein thrombosis, which is a unique differentiator of this study. We are very encouraged by the one-year results and look forward to sharing the data broadly as we seek to expand commercialization globally.”