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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The Vici Venous Stent System comprises two components: the implantable endoprosthesis and its stent delivery system, a 9F over-the-wire system available in a 100cm length and compatible with 0.035in (0.89mm) guidewires
The Opticross 35 catheter is designed for use with a guidewire measuring ≤0.035 in (0.89 mm) in diameter and an introducer sheath of 8F (2.67 mm) or larger. The working length of OC35 catheter is 105 cm.
The primary patency rate at 12 months post index procedure
Defined as freedom from occlusion by thrombosis AND freedom from surgical or endovascular intervention on target vessel which are found to have restenosis or stent occlusion to maintain patency AND freedom from in-stent stenosis more than 50% by DUS.
Time frame: 12 month
Major Adverse Events within 30 days post index procedure
The composite endpoint of below major adverse events (MAE) adjudicated by the Clinical Events Committee (CEC) within 30 days post index procedure: * Device or procedure-related death * Device or procedure-related bleeding at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion ≥ 2 units * Device or procedure-related arterial or venous injury occurring in the target vessel segment and/or target lesion or at the access site requiring surgical or endovascular intervention * Device or procedure related acute DVT outside of the target vein segment * Clinically significant pulmonary embolism defined as being symptomatic with chest pain, hemoptysis, dyspnea, hypoxia etc… AND be documented on CT * Stent embolization * Stent thrombosis
Time frame: 30 days
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