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Clinical Trial Summary

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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT04856592
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Not yet recruiting
Phase N/A
Start date May 30, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT02112877 - VIRTUS: An Evaluation of the Viciā„¢ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction N/A