Chronic Venous Disorder Clinical Trial
Clinical Outcomes of Intravascular Ultrasound-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction
The APAC VICI Study is a prospective, non-randomized, multicenter, single-arm study. The purpose of this study is to evaluate the clinical results of using the Boston Scientifc's Vici Venous Stent (Vici stent) to treat significant blockage in the iliofemoral veins under the guidance of intravascular ultrasound (IVUS) in ethnic Chinese patient population. The study will assess the safety and effectiveness of Vici stent implanted under the guidance of the Boston Scientific's IVUS technology (by using Opticross 35 catheter) for treating adult ethnic Chinese patients with symptomatic chronic venous obstruction in the iliofemoral veins. During the trial, anticoagulant or antiplatlet therapy will be administered for 6 - 12 months post index procedure. Ongoing dynamic data safety monitoring will be performed throughout the trial to minimize subject risk. All enrolled subjects receiving the Vici stent treatment will be followed for 24 months post index procedure.
|Source||Boston Scientific Corporation|
|Status||Not yet recruiting|
|Start date||May 30, 2021|
|Completion date||December 31, 2023|